EPILEPSY YOU'RE NOT ALONE

Staying Healthy and Healing The Body Naturally: Viva Labs, Inc. Announces the Debut of a Powerful ...

2012-03-09T21:05:00.001-05:00

Staying Healthy and Healing The Body Naturally: Viva Labs, Inc. Announces the Debut of a Powerful ...: Viva Labs, Inc. Announces the Debut of a Powerful New Fish Oil Product: Omega Select™ Viva Labs, Inc, an international leader in ...

Staying Healthy and Healing The Body Naturally: The Getting to Know Yourself, "Exercise" The Spiri...

2012-03-09T08:16:00.001-05:00

Staying Healthy and Healing The Body Naturally: The Getting to Know Yourself, "Exercise" The Spiri...: Spiritual Healing - Open Air - 2005 (Photo credit: Udo Herzog ) Here are exercises to help you i...

Staying Healthy and Healing The Body Naturally: Taking Care of yourself Emotionally

2012-03-06T14:27:00.000-05:00

Staying Healthy and Healing The Body Naturally: Taking Care of yourself Emotionally: HEALTHY LIVING The Most Important Secrets You Must Learn Image via Wikipedia In Order To Look And Feel Your Best Ta...

Negative Perceptions Of Epilepsy Via Twitter

2012-03-03T09:24:00.005-05:00

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A revealing study published in Epilepsy & Behavior provides evidence that the perception of epilepsy is not faring well in social media. Kate McNeil and colleagues from Dalhousie University in Canada analyzed data collected from Twitter to provide a snapshot of how epilepsy is portrayed within the twitter community.

Twitter, a social networking platform launched in 2006, allows its users to communicate through posting of "tweets" limited to 140 characters. Twitter has gained worldwide popularity since its inception, with approximately 110 million tweets per day from 200 million users worldwide counted in January 2011. Twitter's role in a number of revolutions, including the 2011 Egyptian revolution and the 2010-2011 Tunisian protest, has confirmed its ability to influence culture and perceptions on a global scale.

In their study McNeil and colleagues analyzed 10,662 tweets collected during one week in April 2011 mentioning the word "seizure" or "seizures". They found that 41% of these seizure-related tweets were considered to be derogatory in nature.

Fortunately there were a few tweets that spoke out against mocking those with seizures. For instance, "Why do people joke about epilepsy and seizures? Do they joke about cancer? Attach your brain 2 a car battery & see how funny it is!" articulates this point emphatically. The researchers do argue, however, that the online voices of those speaking out against such negative stereotypes and disparaging remarks need to be stronger. They emphasize the need for improved epilepsy education to advance public knowledge and behavior on the topic.

The study concludes that although Twitter could hold the power to positively affect how epilepsy and seizures are perceived, currently an epilepsy stigma is being perpetuated instead.

"While we are well aware of the stigma faced by people with epilepsy, we were shocked to see just how pervasive the problem is in social media. It certainly emphasizes a need for public campaigns to combat these negative attitudes," said Dr. Brna, corresponding author of the study, based at Dalhousie University in Canada.

Dr. Joseph Sirven, Professor of Neurology and Chair of the Department of Neurology at Mayo Clinic in Arizona, in an accompanying editorial wrote, "It is now time for the epilepsy community to rise up, have our own Twitter revolution, and alter the way the condition is perceived. There is too much suffering and too great a burden for this to go unchecked...By taking charge, we can potentially change the equation and allow the silent voices of individuals with epilepsy to rise up, revolt, and finally correct the misperceptions and eliminate the stigma associated with the condition once and for all."

Preventing Epilepsy Seizures

2012-02-23T09:41:00.000-05:00

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Seizures can occur for a number of reasons and often they can be prevented. One common cause of seizures is epilepsy, and in most cases, seizures associated with the condition can be prevented if you know what's triggering them and take steps to modify or avoid those triggers.

Epilepsy Causes, Treatment, and Prevention

Epilepsy — a disorder in which a person has recurring, unprompted seizures due to abnormal electrical activity in the brain — affects an estimated 50 million people worldwide. In about half of those people, the cause of the epilepsy is unknown. Among the other 25 million individuals, the cause may be a defect in the structure of the brain, a tumor or stroke, or a severe head injury — the most common known cause in young adults, according to the Epilepsy Therapy Project. Therefore, it's important to protect your head with a helmet any time you're engaged in an activity in which your head could be damaged, such as playing a contact sport like football or riding a bicycle, all-terrain vehicle, or motorcycle.

There are several medications that can successfully treat and manage epilepsy and help keep seizures to a minimum. Anticonvulsant drugs can work if taken correctly. In some cases, a low carbohydrate, high-fat diet known as the ketogenic diet may be prescribed to help treat children with epilepsy and prevent seizures.

Know Your Triggers, Prevent Seizures

Epileptic seizures are often associated with particular triggers or changes in your daily habits or routine. Here are some common behaviors and factors that may trigger an epileptic seizure:

Stress, anxiety, or other emotional issues
Alcohol or drug abuse or the process of quitting alcohol or drugs
Change in sleep schedules, feeling very tired, or significant sleep deprivation
A change in medications, or skipping or missing a dose of anti-seizure medication
Something that overstimulates the senses, like lights that flash brightly, watching television, playing video or computer games, or working on a computer
Hormonal changes in women, often from pregnancy or menstruation
Mental strain, such as from solving complex problems

You can't always predict what will trigger an epileptic seizure; sometimes they'll occur for no apparent reason. But many people are able to see a correlation between certain behaviors and their seizures. By taking steps to minimize these factors, you may be able to prevent seizures.

Seizure Prevention Tips

Here are some tips that may help reduce your risk of having an epilepsy seizure:

Get plenty of sleep each night — set a regular sleep schedule, and stick to it.
Learn stress management and relaxation techniques.
Avoid drugs and alcohol.
Take all of your medications as prescribed by your doctor.
Avoid bright, flashing lights and other visual stimuli.
Skip TV and computer time whenever possible.
Avoid playing video games.
Eat a healthy diet.

Until more is known about the causes of epilepsy and how it can be prevented, your best bet to prevent seizures associated with epilepsy is to avoid the things that can trigger your seizures. This can make a measurable difference in the number of seizures you have.

It's a Seizure, But Is It Epilepsy?

2012-02-23T09:34:00.002-05:00

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A moment of unresponsiveness; the inability to recall what just happened; convulsions or jerking movements; sudden stiffness of the body: These are classic symptoms of an epilepsy seizure. An epilepsy seizure is triggered by abnormal electrical impulses in the brain.

And while these symptoms may indicate epilepsy, other brain abnormalities or injuries could also lead to seizures.

What is a Non-Epileptic Event?

A non-epileptic seizure, or non-epileptic event, is a seizure that isn't caused by epilepsy but looks the same. These may be caused by a change or difference in electrical activity in the brain, but not an electrical disruption of the type that triggers an epileptic seizure.

There are two types of non-epileptic seizures, called psychogenic and physiologic. A psychogenic non-epileptic seizure can be brought on by some sort of emotional stressor or trauma. It's a legitimate seizure and should be treated that way, but it is not caused by a problem in the brain.

A physiologic non-epileptic seizure can be triggered by some sort of change in the brain — typically a change in the supply of blood or oxygen rather than electrical activity. Some possible causes of physiologic non-epileptic seizures include:

Rapid drop in blood pressure
Low blood sugar levels
Irregular heartbeat

Causes of Seizures

All types of seizures, including those not associated with epilepsy, can have a number of causes, including:

A brain injury
A brain tumor
Changes in metabolism (e.g., low blood sugar) from health conditions like kidney and liver problems
An infection throughout or in a particular part of the body (including infection in the brain)
Drug use or withdrawal
Alcohol use or withdrawal
A congenital health problem, like Down's syndrome
Stroke
Alzheimer's disease

Febrile Seizures

These seizures are caused by high fevers, and occur most commonly in infants and young children. Febrile seizures are quite common, affecting 1 in 25 children. While frightening, these seizures don't cause brain damage or otherwise harm children.

During the seizure, the child may be unconscious, shake, and convulse. Febrile seizures can last longer than 15 minutes or less than a few seconds, but most commonly last one to two minutes.

Febrile seizures typically strike when a child is between 6 months and 5 years old, but they most often occur during the toddler years. These types of seizures may recur during childhood but are usually outgrown.

First Seizures

A first seizure is just what it sounds like — the first seizure a person has. The underlying cause may be determined to be epilepsy, but often the cause can't be determined.

These isolated seizures are not rare events — up to 5 percent of people in the United States may experience a first seizure that isn't due to fever or epilepsy. A first seizure typically occurs before age 25, with most taking place in those younger than 15. First seizures seem to strike males a little more often than females, and they may not have a specific or detectable cause. A first seizure can affect part of or the entire brain.

Eclampsia Seizures

These seizures occur in pregnant women and are not caused by epilepsy or other brain disorders. The cause of eclampsia is not known, but it often follows the pregnancy condition called preeclampsia, in which the woman’s blood pressure gets abnormally high. Eclampsia occurs in about 1 out of every 2,000 to 3,000 expectant women. The seizures cause convulsions or changes in personality such as agitation.

All seizures — whether epileptic or non-epileptic — should be evaluated and treated. Determining what's causing the symptoms, and if there's an underlying condition, is vital to staying safe and helping to prevent all types of seizures.

Staying Healthy and Healing The Body Naturally: About Us

2012-02-19T11:06:00.000-05:00

Staying Healthy and Healing The Body Naturally: About Us: HEALTH COMES FIRST Helping To Improve the Life's of Others IF YOU DREAM IT, YOU CAN DO IT ! ALTERNATIVE MEDICINE A Dream I...

Preventing 'Absence Seizures' In Children: New Drugs Show Promise

2012-02-17T19:21:00.001-05:00

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A team led by a University of British Columbia professor has developed a new class of drugs that completely suppress absence seizures - a brief, sudden loss of consciousness - in rats, and which are now being tested in humans.

Absence seizures, also known as "petit mal seizures," are a symptom of epilepsy, most commonly experienced by children. During such episodes, the person looks awake but dazed. The seizures, arising from a flurry of high-frequency signals put out by the neurons of the thalamus, can be dangerous if they occur while a person is swimming or driving, and can also interrupt learning.

Available medications don't completely control such seizures in many patients. They also cause severe side effects, including sleepiness, blurred vision and diminished motor control.

A Canadian-Australian team, led by neuroscientist Terrance P. Snutch, a Canada Research Chair in the Michael Smith Laboratories at UBC, developed new drugs with a different target - the flow of calcium into brain cells. Their findings were published in Science Translational Medicine.

The new drugs, known as Z941 and Z944, block the flow of calcium ions into those neurons. When given to rats with absence epilepsy, they suppressed seizures by 85 to 90 per cent.

The team, which included collaborators at Zalicus Pharmaceuticals Ltd. of Vancouver and the University of Melbourne, was surprised to find that when seizures did occur, they were also of shorter duration; existing medications don't have any effect on the length of seizures.

The first phase of human clinical trials of Z944 began in December, with results expected later this year.

"Z941 and Z944 were designed to target a specific type of nerve cell calcium channel associated with epilepsy, as well as other hyper-excitability disorders such as chronic pain," says Snutch, a professor in the departments of psychiatry and zoology. "The dramatic effect of the drugs in rats with absence epilepsy, together with the drugs' ability to be administered orally and easily absorbed, and its good safety profile in animals, provide us with cautious optimism for the current clinical trial."

Staying Healthy and Healing The Body Naturally: How to Cure Anxiety Naturally

2012-02-17T11:04:00.000-05:00

Staying Healthy and Healing The Body Naturally: How to Cure Anxiety Naturally: Image via Wikipedia Treatments Conventional treatments center on anti-anxiety drugs such...

What Is Continuous Spike-Wave in Slow Wave Sleep Syndrome? (A RARE EPILEPSY)

2012-02-16T23:17:00.003-05:00

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Continuous spike-wave in slow wave sleep syndrome (CSWS) is a rare epilepsy syndrome in which children lose a wide range of developmental abilities, including language, motor skills, memory, and visuospatial skills. This syndrome occurs in school-aged children. Development prior to onset of CSWS may be normal, but children with CSWS often have some pre-existing learning difficulties. In many children there is no known cause of epilepsy, although some children are found to have abnormal brain formation or have a prior history of brain infection. We still do not understand how these structural changes result in the continuous EEG discharge.

Many, but not all, children with CSWS also have seizures. There can be many different seizure types, including absence, generalized tonic-clonic, and focal seizures. The seizures can be difficult to treat. Even in those who already had learning difficulties, there is a clear loss of skills across multiple developmental domains.

What Other Symptoms Can I Expect In CSWS?

In addition to the developmental regression, most children with CSWS also have significant new-onset behavior, learning, and attention difficulties. The behavior problems are not thought to be the direct result of the new communication difficulties. Rather, the thought processes that control how we organize our thoughts, control our impulses, and react to changing situations are impaired in CSWS. Children are commonly diagnosed with attention deficit hyperactivity disorder (ADHD). Going to sleep and staying asleep can also be a significant challenge. Many of these symptoms improve when CSWS is treated, but may not go away completely. It is important to understand that these are symptoms of the disease, rather than intentional behaviors.

How Is CSWS Diagnosed?

CSWS is diagnosed based on the history you provide and your child’s electroencephalograph (EEG), a recording of electrical activity of the brain. The EEG during wakefulness in these children often shows intermittent abnormalities that would be expected in a child with epilepsy. When the child goes to sleep, there is a marked increase in discharges or excessive brain wave activities. These increased discharges are not ongoing seizures during sleep. When the child awakens, these discharges resolve. This EEG pattern is called Electrical Status Epilepticus in slow wave Sleep (ESES). An overnight EEG is typically required to confirm the ESES. A global regression of developmental skills and an EEG demonstrating ESES must be present to make the diagnosis of CSWS.

It is important to ensure the regression is not due to other pediatric disorders, such as epileptic encephalopathy, pervasive developmental disorders (autistic spectrum disorders), or developmental language disorders. CSWS should also be differentiated from a similar epilepsy syndrome, Landau Kleffner Syndrome (LKS), which is a rare epilepsy syndrome in which children lose language abilities [see My Child Was Diagnosed with Landau Kleffner Syndrome. What Do I Need To Know?].

How Is CSWS Treated?

Since CSWS is such a rare syndrome, there is no “best” treatment. Although the seizures may be easily treated with seizure medications, the EEG abnormalities must also be treated to allow the child to learn and recover language function. Many different treatments have been suggested, including high dose benzodiazepines (Valium/diazepam), high dose steroids (prednisone and ACTH), and some anti-seizure medications. Rarely, intravenous gamma-globulin (IVIG) and ketogenic diet have been used. It is important to recognize that some anti-seizure medications, such as phenytoin, carbamazepine, and oxcarbazepine, can make the EEG and learning problems worse.

Children with CSWS do typically respond to treatment. With treatment, the EEG pattern of ESES goes away. However, recurrent relapses can occur. With each relapse, the child once again has a decline in language skills and the EEG shows recurrence of the ESES pattern. Each relapse needs to be treated aggressively to ensure resolution of the ESES.

In addition to the seizures and EEG abnormalities, the other symptoms of CSWS must also be treated. Medications typically used to treat ADHD, psychostimulants, often provide some benefit to improve poor impulse control and hyperactivity. Melatonin may be used to help sleep difficulties. Behavior modification is also important. Consistent limits and routines are essential. It is also important to work with the child’s school to ensure proper academic support is available. Most children with CSWS have Individualized Education Plans (IEP). When children are working on academic tasks, distractions should be limited.

What Is The Long-Term Outcome for Children with CSWS?

Fortunately, the seizures in CSWS improve as the child approaches adolescence and may resolve completely. Similarly, the EEG abnormalities also resolve spontaneously. However, the learning and cognitive problems remain a problem. Normal language and learning is seen in only a minority of children. Children with learning and developmental abnormalities before onset of CSWS are unlikely to have a normal developmental outcome. Although language and learning improve with treatment, the recurrent episodes of relapse and ESES have a significant and lasting impact. The most important predictive factor for learning outcome is how long the child has been exposed to ESES. Therefore, those with onset at a younger age and those who do not respond to treatment, or have treatment delayed, are more likely to have abnormal language and learning in adulthood.

How Is CSWS Different From Landau-Kleffner Syndrome?

Although there are many similarities between continuous spike-wave in slow wave sleep syndrome (CSWS) and Landau-Kleffner syndrome (LKS), these are recognized as two separate syndromes. Both are rare epileptic syndromes that present with regression and behavior problems in school-aged children, but there are important differences in the cause of epilepsy, the type of developmental regression seen, and in the ability to treat seizures.

Children with CSWS often have abnormal learning, brain formation, or other risk factors for epilepsy before onset of CSWS. In contrast, children with LKS have normal development and have no epilepsy risk factors, making this truly a syndrome of unknown cause. The regression in LKS is primarily in the ability to understand language, but other developmental abilities are essentially normal. By comparison, the children with CSWS can understand language, but have trouble speaking. They also lose developmental skills other than just language. Finally, the seizures in LKS are typically infrequent and easily treated. The seizures in CSWS can occur frequently and may be difficult to treat.

Vigabatrin - What Makes This Drug Different

2012-02-15T18:34:00.001-05:00

Vigabatrin has been available around the world for nearly 2 decades. It was approved by the U.S. Federal Drug Administration in 2010 for the specific indications of infantile spasms in children as well as refractory partial epilepsy in adults where all other options have failed.

Vigabatrin’s exact mechanism of action is unknown; however, it is believed that it exerts its anti-seizure effect as a result of its action as an irreversible inhibitor of g-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA.

This action results in increased levels of GABA in the central nervous system. There is no direct correlation between the serum concentration of the drug and the effectiveness of the drug. The duration of the drug effect is unique because it is actually dependent on the rate of the individual’s enzyme resynthesis rather than on the rate of elimination of the drug from the systemic circulation. This makes the drug quite different from other agents in that monitoring serum levels are rendered almost obsolete, because the drug is individually tailored to the patient’s physiology based on one’s GABA receptors.

Effectiveness

VGB is approved for use for 2 particular indications in the United States; complex partial seizures in adults and the other is for infantile spasms in children.

Infantile Spasms

The effectiveness of vigabatrin in monotherapy for infantile spasms has been established in 2 multi-centered, controlled studies. Both studies were similar in terms of the population studied and seizure characteristics of enrolled patients. In the first study, a multi-centered, randomized, low-dose, high-dose, parallel group, partially blinded, caregivers knew the actual dose, but not whether their child was classified as high- or low-dose; the EEG reader was blinded, but investigators were not blinded; study to evaluate the safety and efficacy of vigabatrin in patients less than 2 years of age with new onset infantile spasms. The total number of children studied was 221. The primary efficacy endpoint of the study was to proportion the patients who were spasm free for 7 consecutive days, beginning within the first 14 days of vigabatrin therapy. Patients with both symptomatic and cryptogenic etiologies were studied with infantile spasms. The study comprised of 2 phases. The first phase was a 14-21 day partially blind phase in which patients were randomized to either receive a low dose, 18-36 mg/kg/day, or a high dose, 100-148 mg/kg/day, of vigabatrin. The study drug was titrated over 7 days followed by a constant dose for 7 days. If the patient became spasm free on or before day 14, another 7 days of constant dose was administered. Seventeen patients in the high-dose group achieved spasm freedom compared to 8 patients in the low-dose group, which was statistically significant at p=0.0375.

The second study was a multi-centered, randomized, double-blind, placebo-controlled, parallel group study consisting of a pre-treatment baseline period of 2 to 3 days followed by a 5-day, double-blind, treatment phase during which patients were treated with vigabatrin initial dose of 15 mg/kg/day with a titration allowed to 150 mg/kg/day. The total number of children studied was 40. In the second study, no statistically significant differences were observed in the average frequency of spasms using a 2-hour evaluation window; however, a post-hoc alternative efficacy analysis using a 24-hour clinical evaluation window found a statistically significant difference in the overall percentage of reductions in spasms between the vigabatrin group of 68.9% and the placebo group of 17% (p=0.030). Based on these 2 studies, the drug was approved for the indication of infantile spasms.

Complex Partial Seizures in Adults

The effectiveness of several as add-on therapy in adult patients with complex partial seizures was established in 2 U.S. multi-centered, double-blind, placebo-controlled, parallel-group clinical studies. A total of 357 adults, age 18 to 60 years, with complex partial seizures with or without secondary generalization were enrolled. Patients were required to be on an adequate and stable dose of an anticonvulsant and have a history of failure on an adequate regimen of either carbamazepine or phenytoin. Patients had a history of about 8 seizures per month for about 20 years prior to entrance into the study.

In the first study, a randomized, double-blind, placebo-controlled dose response study consisting of an 8-week baseline followed by an 18-week treatment period, patients were randomized to receive placebo or 1, 3, or 6 g of vigabatrin per day administered twice daily. During the first 6 weeks following randomization, the dose was titrated upward beginning with 1 g/day and increasing by 0.5 g/day on days 1 and 5 of each subsequent week in the 3 g/day group and 6 g/day group until the assigned dose was reached. The 3 g/day and 6 g/day dose groups were statistically significantly superior to placebo, but the 6 g/day was not superior to the 3 g/day group. The proportion of patients achieving any particular level of reduction in complex partial seizures was consistently higher for the sample of 3 and 6 g/day group compared to the placebo group. For example, 51% of patients randomized in the sample 3 g/day and 53% of patients randomized in sample 6 g/day experienced a 50% or greater reduction in seizure frequency compared to 9% of patients randomized to placebo.

The second study consisted of 183 randomized patients who were placed in a randomized, double-blind, placebo-controlled, parallel study consisting of an 8-week baseline period and a 16-week treatment period. During the first 4 weeks following randomization, the dose of vigabatrin was titrated upward beginning with 1 g/day and increased by 0.5 g/day on a weekly basis to the maintenance dose of 3 g/day. The proportion of patients achieving any particular level of reduction in seizure frequency was consistently higher for the sample 3 g/day group compared to the placebo group. For example, 39% of patients randomized in sample 3 g/day (50%) had a greater reduction in complex partial seizures compared to 21% of patients randomized to placebo.

Adverse Effects

VGB has serious potential adverse effects and carries an FDA black box warning. The drug may cause permanent, bilateral concentric visual field constriction in 30% or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation and can result in disability. In some cases, VGB may damage the central retina decreasing visual acuity. The onset of visual loss is unpredictable and can occur within weeks of starting treatment or sooner or anytime during treatment, even after months or years. The risk of visual loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of visual loss. Unless the patient is formally exempted from periodic ophthalmologic assessment as documented in a special post-marketing program to tightly assess the adverse effects related to this drug entitled “Share Program,” a formal ophthalmologic assessment every 3 months during therapy is required for adults. Visual assessment is also required about 3-6 months after the discontinuation of therapy.

Once detected, visual loss is irreversible. It is expected that even with frequent monitoring, some patients could develop severe visual loss. It is possible that visual loss could worsen despite discontinuation of the drug. Because of this risk of permanent visual loss, the drug is available only through a restricted distribution program with a central pharmacy. Physicians who prescribe the drug need to take special educational classes in order to appropriately handle these issues and counsel patients. As a result, because of this risk and because vigabatrin, when it is effective, provides an observable symptomatic benefit, a patient who fails to show substantial benefit within 3 months of initiation of treatment should be withdrawn from the drug. If it is in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 3 months, treatment should be discontinued at that time. Patient response to and continued need for treatment should be periodically assessed. This is true for both children and adults. The diagnostic approach to assess and monitor vision has been outlined by the pharmaceutical company. Perimetry is recommended, preferably by automated threshold visual field testing. Additional testing may also include electroretinography, retinal imaging, and other methods, depending on the physician’s choice. In patients exempted from visual testing, the treatment may continue according to clinical judgment with appropriate patient counseling.

Outside of the visual adverse effects, other important adverse effects that need to be considered include the presence of somnolence and fatigue, symptoms of peripheral neuropathy, edema and weigt gain. The average weight gained is 3.5 kilograms and this has been reported in 17% of patients.

Dosing

With regards to dosing, for refractory partial epilepsy, 500 mg of the drug is started as twice-daily oral administration with or without food. The total daily dose may be increased in 500 mg increments at weekly intervals depending on the response. The recommended daily dose of vigabatrin is 3 g/day. It is not approved for higher doses.

In children 1 month to 2 years of age with infantile spasms, the drug can be given as a twice-daily oral administration. The initial daily dose of 15 mg/kg/day given in 2 divided doses and can be titrated by 25-50 mg/kg/day in increments every 3 days up to a maximum of 150 mg/day.

Summary

Given the risks of visual loss and the fact that the drug has a very tightly controlled central distribution for this agent, this drug can only really be prescribed by a neurologist. It is often now left as a last option choice for adults who have refractory partial epilepsy. In children with infantile spasms, the drug is often utilized much earlier in terms of choices available as the only alternative choice of drug is an oral ACTH gel and therefore vigabatrin has been very beneficial in providing another option for individuals with this devastating epilepsy type.

Home-grown neuroscientist leads the way for national Epilepsy charity

2012-02-06T08:07:00.002-05:00

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Professor Mark Rees, Chair of Neurology Research at Swansea University’s Institute of Life Science (ILS), has been selected to Chair the Scientific Advisory Committee at Epilepsy Research UK (ERUK).

ERUK is the only national charity that funds independent research exclusively into the causes, treatment and prevention of epilepsy.

Originally hailing from the Gwendraeth Valley in South Wales, Professor Rees has established an expert team at the ILS that works closely with ERUK, gaining some £7million of funding from several sources to investigate epilepsy, particularly in children and young adults.

Two of the team – Dr Seo Kyung Chung and Dr Rhys Thomas – are investigating childhood absence seizures (CAE) and Juvenile Myoclonic Epilepsy (JME) respectively. Dr Chung is the recipient of a prestigious ERUK Fellowship and Dr Thomas is leading a two-year project as part of a UK-wide multi-centre research effort.

Childhood absence seizures, if not diagnosed effectively, can be misinterpreted as not paying attention or ‘day-dreaming’. New findings by Dr Chung will now be followed up to try to describe the biological basis for such seizures and explain how the inner mechanisms of the brain cause CAE.

Once a person develops JME, they have it for life and so long-term treatment plans must be formulated. A good understanding of JME is vital so that these can be as effective as possible.

Dr Thomas and his colleagues hope that the identification of clinical subgroups using DNA sequencing will help develop better diagnostic techniques and therapies, and allow clinicians to make more accurate prognoses for individual patients.

Professor Rees, who also leads the Wales Epilepsy Research Network, said: “I’m delighted to have been appointed as Chair of ERUK’s Scientific Advisory Committee and hope that my increased involvement with the charity will see the continuation of worthwhile projects being funded in this lesser understood condition.

“My congratulations to Dr Chung and Dr Thomas for their recent success and they represent rising stars in the Biomedical and Clinical investigation of epilepsy.

“The research being conducted here at the ILS in Swansea – together with the impact of networks such as the Wales Epilepsy Research Network – really is putting Swansea and Wales on the map for forging new discoveries into epilepsy.

“Over the past few years we have built up a strong knowledge and presence in this field, which is gaining recognition and quietly influencing national decisions and policies.”

Without ERUK funding, continued research into epilepsy would be very difficult to undertake.

This condition, which affects 1% of the population at any one time – or 3% in a lifetime, still needs research resources. Currently, 30% of all cases will remain drug-resistant and suffer recurrent uncontrolled epilepsy.

However, with research made increasingly possible, the prospect of treatments being tailored to individual sufferers through their DNA is becoming ever closer.

Adelaide Researchers Uncovered Cause of Infant Epilepsy

2012-02-06T07:55:00.003-05:00

Epilepsy Awareness Ribbon (Photo credit: Cynr)

Over fifteen years since pinning infant epilepsy to a chromosome but failing to identify the gene responsible, Adelaide researchers have finally solved the mystery of the condition in infants.

Infant epilepsy is caused by a single mutation in one gene, the scientists confirmed.

The mutation causing infant epilepsy adds one more code to a 12-code sequence on chromosome 16, which affects a gene known as PRRT2.

The UniSA researchers made the discovery in conjunction with a team at the University of Melbourne. The work was published on Friday in the American Journal of Human Genetics, the Herald Sun reported.

The recent finding is expected to improve screening, diagnosis and prediction of the risk of seizures for infant sufferers of benign familial infantile epilepsy.

University of South Australia research fellow Dr. Susan Heron said over the weekend that benign familial infantile epilepsy, which is a relatively rare condition, occurred in about 60 Australian families.

She explained the gene they found responsible for infant epilepsy has never been linked to the condition in the past.

"It was difficult to find because it wasn't a gene that you would think about linking to epilepsy," she said.

Of 23 families previously diagnosed with benign familial infantile epilepsy, DNA analysis found the mutation present in 19 families.

Dr, Heron said children with the condition typically suffered seizures from the age of six months to two years.

While the seizures are bound to stop later in life, children with benign familial infantile epilepsy could suffer from a movement disorder when they get older.

"The children grow out of epilepsy but they can develop a movement disorder," Dr. Heron said.

With the research developments, families can now have their children screened for the disorder.

"If we can confirm what they have, we can better target treatment," she said.

The International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE) define an epileptic seizure as a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.

An estimated 50 million people worldwide have epilepsy, and nearly 90% of epilepsy occurs in developing countries, according to a WHO report in 2009.

A Step Closer To Unlocking A Mystery That Causes Epileptic Seizures In Babies

2012-02-06T07:50:00.000-05:00

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Benign familial infantile epilepsy (BFIE) has been recognised for some time as infantile seizures, without fever, that run in families but the cause has so far eluded researchers. However clinical researchers at the University of Melbourne and Florey Neurosciences Institute and molecular geneticists at the University of South Australia have discovered a gene.

BFIE is a disorder that occurs in previously healthy infants who are developing normally. Seizures commence when a baby is about six months old and stop by the age of two years. BFIE is a rare form of epilepsy with the Australian researchers having studied about 40 families from around the world. Some of the children with this gene abnormality develop an unusual movement disorder later in childhood or adolescence called Paroxysmal Kinesigenic Choreoathetosis (PKC).

This movement disorder causes sudden, brief stiffening or twisting of their muscles as the person starts to move, for instance, people with this condition often have difficulty crossing the road when the traffic lights change to green. While this condition can be easily controlled by medication, it impacts on quality of life and may prevent people from participating in some activities.

Families with this condition have now been found to carry a variation in a gene called PRRT2, which may cause the protein the gene encodes to form incorrectly. The function of this gene is not yet known nor is it understood how the changes in this gene cause an infant to have seizures. This gene discovery provides valuable opportunities for learning more about brain function and what causes seizures.

Professor Ingrid Scheffer, Chair of Paediatric Neurology Research said the finding would help families understand why their baby has seizures and will provide reassurance that the baby will grow out of the seizures and not have long term problems. It will also help with early diagnosis and appropriate treatment of the movement disorder.

Guidelines Stress Caution When Combining Anti-Epileptic, HIV Drugs

2012-02-06T07:45:00.001-05:00

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New guidelines from the American Academy of Neurology will help physicians better choose seizure drugs for people on HIV/AIDS medication, avoiding deadly drug interactions and preventing critical anti-HIV drugs from becoming less effective, possibly leading to a more virulent strain of the disease.

Michigan State University's Gretchen Birbeck - who spends several months each year in the sub-Sahara African nation of Zambia researching epilepsy, HIV /AIDS and cerebral malaria - is the lead author of the medical guideline, which was co-developed with the World Health Organization through the International League Against Epilepsy.

The research is published in Neurology, the medical journal of the academy, and Epilepsia, the medical journal of the league.

According to the World Health Organization, more than 33 million people worldwide were living with HIV in 2009. Seizure disorders are common among people with HIV, with up to 55 percent of patients requiring treatment with anti-epileptic drugs, known as AEDs, said Birbeck, a professor of neurology and ophthalmology in MSU's College of Osteopathic Medicine.

Until now, formal treatment guidelines did not exist for those with HIV/AIDS who were in need of AEDs, which treat everything from epilepsy to mood disorders to other neurological ailments.

When certain seizure drugs are combined with HIV/AIDS drugs known as antiretrovirals, or ARVs, one or more of the combined drugs may become less effective or more toxic. Seizure drugs that decrease HIV/AIDS drug levels - such as phenytoin, phenobarbital and carbamazepine - may cause HIV/AIDS drugs to fail.

"Drug interactions between AEDs and ARVs could result in progression to AIDS and/or reduced seizure control," said Birbeck, also a Fellow of the American Academy of Neurology. "Providing guidelines that help physicians select appropriate therapies for their patients with epilepsy and HIV/AIDS will ultimately improve patient outcomes and possibly decrease the public health threat of the development of drug-resistant HIV."

In early 2011, Birbeck was awarded a $245,000 grant from the National Institute of Neurological Disorders and Stroke to conduct a cohort study in Zambia - where rates of epilepsy and AIDS are both high - to provide data on possible drug interactions that could make HIV drugs less effective or the disease drug resistant. Because seizure and HIV/AIDS drug choices are limited in developing countries, the risk of drug interactions is higher in those countries.

"Future research should target epilepsy and HIV/AIDS drug combinations where choices are limited, such as in developing countries, to better understand the risks," Birbeck said. "It also is important that patients know exactly which drugs they are taking and provide that information to all prescribing health care providers caring for them."

To establish the guidelines, Birbeck and colleagues systematically reviewed studies published in the medical literature between 1950 and 2010 to determine the prevalence of co-usage of anti-epileptic drugs and antiretrovirals and drug interactions. Nearly 4,500 articles were identified, 68 full studies were reviewed and data from 42 used in the analysis.

Staying Healthy and Healing The Body Naturally: How Vitamin D Can Help Your Condition

2012-02-04T14:02:00.000-05:00

Staying Healthy and Healing The Body Naturally: How Vitamin D Can Help Your Condition: Vitamin Packaging (Photo credit: colindunn ) Vitamin D What is it, and what does it do? Vitamin D is probably most well-know...

Keppra® Approved By FDA For Childhood Seizures

2012-02-03T15:02:00.002-05:00

Epilepsy Awareness Ribbon (Photo credit: Cynr)

In the U.S., Keppra® has been approved as adjunctive therapy for partial onset seizures in adults and children aged four years and older with epilepsy. However the UCB recently announced that the U.S. Food and Drug Administration (FDA) has now approved to lower the age restriction to include infants from the age of one month and older with epilepsy.

Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB declared:

"As a leader in epilepsy UCB has a responsibility to develop effective medicines that address unmet medical needs. Our continuing development program with Keppra® in young children demonstrates our long-term commitment to epilepsy."   

The FDA granted their approval following a double blind, randomized, multi-centre, placebo-controlled phase III study, which assessed the efficacy and tolerability of Keppra® oral solution (20-50 mg/kg/day) in 116 pediatric patients with refractory partial onset seizures. The patients were aged between one month and four years or younger. Keppra® demonstrated a substantial reduction in the frequency of partial onset seizures during the 5-day evaluation period, with 43.1% in the Keppra® group experiencing a reduction of at least 50% in seizure frequency, compared with 19.6% in the placebo group (p=0.013).

The researchers found that Keppra® was generally well tolerated by all pediatric patients, with the most commonly reported adverse events in 13.3% of patients in the Keppra group experiencing somnolence, compared with 1.8% in the placebo group, whilst 11.7% and 0% respectively suffered from irritability.

Keppra® has been granted marketing authorization in the E.U. as adjunctive treatment of partial onset seizures in infants and young children aged one month to under four years in 2009, by the European Commission.

UCB's growing epilepsy franchise has been based on Keppra® and has since been extended to include Vimpat® (lacosamide), an adjunctive therapy for the treatment of partial onset seizures in patients with epilepsy, which is marketed in the E.U. for those with epilepsy who are 17 years and older, and in the U.S. as a schedule V controlled substance for young adults with partial onset seizures with or without secondary generalization, aged 16 years and older.

Written By Petra Rattue

Staying Healthy and Healing The Body Naturally: How to Get Rid of Your Allergies Naturally

2012-02-02T16:05:00.000-05:00

Staying Healthy and Healing The Body Naturally: How to Get Rid of Your Allergies Naturally: Image by Getty Images via @daylife Allergies. (Photo credit: Monachromatic ) Allergy Relief What are allergies? Alle...

Staying Healthy and Healing The Body Naturally: Fast Foods in a Fast Society - What Can We Do Abou...

2012-01-30T08:51:00.000-05:00

Staying Healthy and Healing The Body Naturally: Fast Foods in a Fast Society - What Can We Do Abou...: Image by H Dragon via Flickr I can go on forever giving you helpful hints on how to eat healthy and how to stay fit, b...

Staying Healthy and Healing The Body Naturally: Preventing Illnesses by Having a Healthy Diet

2012-01-29T22:10:00.000-05:00

Staying Healthy and Healing The Body Naturally: Preventing Illnesses by Having a Healthy Diet: Image via Wikipedia Eating Healthy helps, you prevent illnesses and diseases. Did you know that a he...

Staying Healthy and Healing The Body Naturally: Diet to Alleviate Eye Fluid Retention

2012-01-27T20:11:00.000-05:00

Staying Healthy and Healing The Body Naturally: Diet to Alleviate Eye Fluid Retention: Image via Wikipedia If you are retaining fluid, you can become puffy all over, including under your eyes. When ...

Vitamin B12: The Most Important Nutrient You Need

2012-01-25T07:47:00.002-05:00

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If you aren’t getting enough vitamin B12, it is indeed very important – and you may very well not be thinking about it. One reason you aren’t thinking about it is that we tend to fall in (and out!) of love with one nutrient at a time (such as vitamin C, beta carotene, lycopene and so on), and vitamin B12 isn’t the nutrient du jour. But the other reason you may not be thinking about it is … because you can’t. A deficiency of vitamin B12 can limit your ability to think clearly about anything! (More on that momentarily.)

Like all vitamins, B12 is an organic compound, made from carbons (as opposed to minerals, which are inorganic), and essential for our normal metabolic function and health. Also, like most vitamins, B12 plays a wide variety of roles in our metabolism. The short list of important effects B12 has on your health includes these:

Vitamin B12 is essential for the manufacture of red blood cells; a deficiency leads to a characteristic kind of anemia
Vitamin B12 is needed to support the normal function of nerve cells, and to manufacture myelin, the insulating material that surrounds some of our nerve cells and speeds neural transmission
Vitamin B12 is required for the replication of DNA

Each of these effects is obviously quite important, but note the third one in particular. When B12 is deficient, our DNA cannot replicate normally – meaning we can’t generate new, healthy cells. As a result, vitamin B12 deficiency can mimic all of the effects of aging.

Common manifestations of vitamin B12 deficiency include weakness, numbness and tingling, fatigue, dizziness, swelling and irritation of the mouth and tongue, and irritability. Anemia can develop, as noted, but a high intake of folate can compensate for a deficiency of vitamin B12 and prevent anemia.

The most serious manifestation of B12 deficiency is impaired brain function, due to the effects of B12 on nerve cells. Advanced B12 deficiency causes dementia severe enough to resemble Alzheimer’s disease. Generally, though, the dementia caused by B12 deficiency is completely reversible with supplementation. While folate can prevent B12-deficient anemia, it cannot prevent the dementia – only B12 itself can do that job.

Vitamin B12 is found in animal foods (and fortified cereals), so vegans are vulnerable to deficiency. But the most important cause of deficiency has to do with the unique way B12 is absorbed. To get into the bloodstream, B12 must be escorted by a protein called intrinsic factor, produced by cells of the stomach. Many disorders of the stomach, such as gastritis, particularly common after age 50, can interfere with the production of intrinsic factor. This condition is called pernicious anemia. Medications that affect the stomach – such as aspirin, antacids and proton-pump inhibitors – can also interfere with intrinsic factor production and result in B12 deficiency. The commonly used diabetes medication, metformin (Glucophage), can do so as well.

For garden-variety B12 deficiency, due to inadequate intake from food or supplements, oral supplementation suffices to fix the problem. But pernicious anemia cannot be treated with oral B12, because the lack of intrinsic factor will prevent absorption. The appropriate treatment is B12 injections your doctor must provide. In some cases, genetic mutations can limit the ability to metabolize B12 as well, in which case you will need to get the active form, called methylcobalamin, instead of the more common cyanocobalamin.

Epilepsy in the Eyes of a Friend

2012-01-21T22:01:00.001-05:00

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Epilepsy in the Eyes of a Friend

Sarah J. Blake

Melanie told me that she rolled around during her seizures and that at times they were very violent. I thought I could handle it, but I was afraid the first few times she had seizures around me. I was not afraid of getting hurt. I was afraid of my own lack of knowledge and understanding.

I asked a lot of questions and did a lot of research. I quickly learned how to respond to her seizures without hurting either of us, keeping her hands away from her mouth but still giving her the freedom to move. I learned over the first few weeks how to recognize the onset of her seizures and help her get to a safe place. I learned to expect any of a number of seizure types and how to tell if the seizure might last a few minutes or 30 minutes. I learned that her seizures sometimes came in groups and how to recognize when she might have more than one.

I also learned that other people did not understand seizures. Some believed that her seizures were intentionally self-destructive, and one person told me that I did not need such behavior in my home and emphasized many times that he thought that Melanie needed 24-hour psychiatric treatment. I wanted Melanie to be accepted and to have a chance to build friendships and have a successful, happy life. I was afraid that other people would not accept her or me as her friend.

During Melanie's first couple of months as my roommate, we experienced quite a few negative reactions from other people. When she had seizures at the church we were attending, someone usually called an ambulance whether we wanted them to call or not. The nurses at the hospital did not seem to want to treat her seizures. When she went to the emergency room, she was usually put in a bed on a heart monitor and ignored. Four or five hours later, someone would check her blood levels and the doctor would increase the dosage of her two medications. Eventually she stopped going to the hospital, even when she needed treatment for the condition known as status epilepticus, which refers to multiple seizures which occur one after the other.

For a while we attended another church because of the reactions of the people at our church. But we missed the original church and later began attending there again. There was a new associate pastor who was very understanding. We have also talked with the pastor about our desire for an ambulance to not be called unnecessarily.

Usually the first thing people wanted to know when Melanie has seizures was whether or not she had a doctor and was taking medication correctly. We had to explain that Melanie's seizures are not entirely controlled and that some of them may not be caused by epilepsy. She also has events which are called pseudoseizures. The doctors have mostly assumed that all of the seizures she has are pseudoseizures.

As a general rule, we did not let the possibility of seizures keep us from doing most things. If Melanie had a seizure in public, I and whoever else was with me calmly explained to people who asked if they should call an ambulance that she was having a seizure and that it would end shortly. Her seizures usually last less than five minutes. If someone did happen to call an ambulance, she was usually alert again by the time it arrives and told the EMT that she did not want to go to the hospital. We lived in a small town and had to use EMS enough that we knew all of the paramedics and drivers. They did not question her decision.

The most frustrating thing about Melanie's seizures is the effect they have on her education and career options. She was not able to complete her junior year of high school because of her seizures and was held back. She was also placed in nonacademic classes. During the second junior year (1994-1995) she also had to withdraw from school. She tried to attend school again in the fall of 1995, thinking that the new school district would handle things better. At first, people's attitudes were positive. Melanie is very bright, and the teachers seemed excited about working with her.

During the six weeks before school started, Melanie did not have any seizures. She was not taking any medications. We thought that this was a good sign that things might go well for her. She was excited when she left for school the first day.

When I met her at the bus after school, she seemed tired and kind of confused. She said that she was fine. I suspected that she had had a seizure at school, but she did not tell me about it. The next day my suspicion was confirmed. I received a phone call from someone at the school who told me that Melanie had had another seizure and was being sent home. Two days later, Melanie got on the bus while apparently having a seizure. On the bus the seizure generalized and became a grandd mal seizure. She had three more seizures at school that day and was home two hours later.

We became concerned about the effect of the school's actions on her grades, but when we asked we got no answers. Melanie was placed on home-bound instruction. She missed many of these lessons because of seizures as well. Eventually, she withdrew again from school. In 1996, she enrolled again in school and was placed on homebound instruction. She graduated in January, 1998, at age 21.

Watching Melanie struggle with decisions about college and her career is difficult. How would she get access to notes she might have missed as a result of a seizure? How would the professors and other students respond? Employers tend to be unwilling to hire someone with seizures, especially seizures that are uncontrolled. How difficult will it be for her to get a job? She originally wanted to teach in a special education classroom, but owners of child care facilities have balked at the prospect of someone with seizures being around the children.

Over the years, Melanie learned a lot about controlling anxiety, which resulted in better seizure control. We don't talk about seizures much now, and I often wonder if she thinks about the things that happened in the past and how she is coping. I don't know whether the best thing for me to do is to let things go or whether there is some way i can help her move on.

The interaction of her seizures and emotional health has been by far the most difficult thing for me to watch. Melanie is bright and very capable. It hurts me to see her so disabled by depression and anxiety. Because she was not diagnosed with epilepsy, it was sometimes difficult for her to get the medications which gave her a moderate amount of seizure control. Therapists do not generally understand pseudoseizures and try to treat them solely as a behavioral problem rather than an anxiety-related problem. Thus the causal issues are never addressed. Most of all, I worry that she despises herself because of any perceptions she might have about the fact that the seizures were psychogenic. Although I no longer take care of her physically and she in fact does not need this, I don't suppose i will ever stop caring so deeply about how she feels and how she is treated... And I don't suppose I can forget that the seizures also had an emotional effect on me. That is something I don't know how to describe--and I don't know that my description would be respectful of Melanie's dignity even though I respect her completely as a person.

I would like to see more people come to understand seizure disorders and disabilities in general. I have been told that I was "taking care of" Melanie. I made mistakes along the way in my friendship with Melanie. I probably did too many things for her that she could and should have done for herself. But I never considered her special needs to be a burden on me. I care about her as my friend and work with and around whatever barriers keep her from participating in life. Being a friend involves reaching out and assisting when assistance is needed. People with disabilities sometimes need more assistance than "normal" people, but the ability to share feelings, dreams, and happiness makes every bit of responsibility worth taking.

Fort Campbell mom fights for daughter with severe form of epilepsy

2012-01-15T22:26:00.000-05:00

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Last year, Fort Campbell mom Felicia Harris contacted congressmen and senators, looking for help for a daughter with a severe form of epilepsy. Now, after witnessing the generosity of many, the Harris family is sharing a very different story.

"We can't even explain how happy we are and how thankful we are," said Felicia Harris.

"It's wonderful," added Spc. Joshua Harris. "It's nice being able to go out and do things we couldn't before."

When we first shared the Harris family's story a year ago, 3-year-old Lexy was suffering constant seizures due to Dravet syndrome, a severe type of epilepsy.

"At its worst, she would have hours and hours of seizures," said Felicia Harris. "One would start right after another one stopped. She'd fall asleep, wake up and have another one."

With Joshua Harris deployed to Afghanistan, Felicia Harris began a fight at home to help her daughter. An expensive medication called Stiripentol wasn't FDA approved, meaning the military's health care provider, Tricare, couldn't cover it.

"She'd be in bed for days," said Felicia Harris. "She wouldn't be mobile or anything because she'd be so sore from the seizures."

One day last year, right when Joshua Harris arrived home from Afghanistan, everything changed.

Fort Campbell's Blanchfield Army Community Hospital stepped in to pay for Lexy's medication.

"With the medication, her seizure control's great," said Felicia Harris. "She has maybe two a month that are less than one minute."

Meanwhile, money donated by those who heard Lexy's story has gone to paying for the family's second golden retriever, which will join the family later in the year and has been trained to know when a seizure is coming.

"We're thankful for everybody's help, everybody's participation," said Felicia Harris. "The support has been great. We're just thankful for what we have."

New drugs for epilepsy, pain are focus of NeuroTherapeutics’ $47.5M round

2012-01-09T17:44:00.002-05:00

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A Chicago biopharmaceutical company developing new ways to treat pain, epilepsy and other nervous system disorders is following up a $43 million series B round of funding in 2010 with another round of up to $47.5 million.

NeuroTherapeutics Pharma Inc. is developing a new class of medicines for neurological and neuropsychiatric conditions that includes its lead molecule, NTP-2014.

In its new round of funding, the company has already secured $12 million from eight investors. Its existing investors include Boston’s Fidelity Biosciences and MPM Capital, Pfizer, and GlaxoSmithKline’s venture fund, SR One.

The series B round in 2010 was expected to carry the drug through proof-of-concept phase 2 trials in 2011 and help expand the company’s pipeline of treatments for neurological disorders. At that time, NeuroTherapeutics Pharma was preparing the compound for an Investigational New Drug application with the U.S. Food and Drug Administration.

Safe and adequate control of pain and epilepsy are unmet medical needs, the company says, as current treatments lack efficacy or cause significant side effects. The market for antiepileptics is expected to experience slow growth between now and 2020 due to increasing use of generics, according to a market report from Decision Resources.

NeuroTherapeutics Pharma is led by CEO Stephen Collins, a former senior director of CNS and pain at Johnson & Johnson, and a former faculty member in the Department of Neurology and Neurosciences at Case Western Reserve University. A message left for a company representative was not returned Thursday.

Supernus Pharmaceuticals Raises $42 Million to Prepare for Launch of Product Candidates in Epilepsy and Develop Pipeline in ADHD

2012-01-09T17:38:00.000-05:00

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Two Transactions in December Bring Total Raised in Non-Dilutive Financing to More Than $165 Million

Supernus Pharmaceuticals, Inc. today announced that in December 2011 it closed two transactions through which it raised $42 million. The sale of its TCD Royalty Subsidiary, which was established in April 2008 to securitize royalties that were generated by Sanctura XR® and Oracea®, generated $27 million, while the second transaction, the issuance of venture debt, generated $15 million. Proceeds from the transactions will be used to prepare for the commercial launch of its two lead product candidates in epilepsy and to further the development of its pipeline designed to treat central nervous system (CNS) diseases.

"We have been able to raise more than $165 million through a series of five non-dilutive financing transactions that have enabled us to progress two epilepsy product candidates into NDA stage and two other product candidates in the ADHD area into Phase II. Since its inception six years ago, and despite the continued challenging financing environment, Supernus has developed a broad and diversified portfolio of product candidates that provides us with multiple opportunities to achieve our goal of becoming a leading CNS specialty pharmaceutical company,” said Jack Khattar, President and Chief Executive Officer.

About Supernus

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The company’s extensive expertise in product development has been built over the past 20 years: initially as a stand alone development organization, then as a U.S. subsidiary of Shire plc and, upon its acquisition of substantially all the assets of Shire Laboratories Inc. in late 2005, as Supernus Pharmaceuticals. The company is developing several product candidates in neurology and psychiatry to address large market opportunities in epilepsy and ADHD including ADHD patients with impulsive aggression. These product candidates include SPN-538 (extended-release topiramate) and SPN-804 (extended-release oxcarbazepine) for epilepsy, SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.

Supernus’ proprietary technologies have been used in the following approved and marketed products: Carbatrol®, Equetro®, Adderall XR®, Sanctura XR®, Oracea® and Intuniv®.

Supernus and the Supernus Pharmaceuticals logo are registered trademarks of Supernus Pharmaceuticals, Inc. in the United States. All other trademarks are the property of their respective owners.

Stress Caution When Combining Anti-Epileptic, HIV Drugs

2012-01-09T17:28:00.000-05:00

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The Herbal LADY'S SLIPPER & Epilepsy

2012-01-06T08:54:00.003-05:00

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LADY'S SLIPPER

Did you know…?

Overview:

The root of Lady'sSlipper is called "Nature's Tranquilizer" and is usedprimarily as a gentle tonic to calm the nerves and ease tension,anxiety and stress. Often called the American Valerian, it is alsothought to relieve depression, recurring headaches and hyperactivity inchildren.

Plant Description:

Lady'sSlipper is a perennial plant that is native to the woods and meadows of NorthAmerica. The fleshy rootstock produces several rounds, hairy stems withalternate leaves and characteristic golden yellow flowers, lined with purple,blooming from May to July.

Thisbeautiful member of the orchid family has a characteristic lower lip that formsan inflated sac, which suggests the shape of a moccasin, thereby giving theplant one of its common names, Moccasin Flower. Lady's Slipper is apungent, bittersweet herb with an unpleasant odor and thrives in moist,humus-rich soil in an open or shady situation, growing to about two feet inheight. Like many other native orchids, Lady's Slipper is becoming increasinglyrare, and its history as an ornamental is as rich as its distinguishedmedicinal past.

History:

Theplant was widely employed by Native Americans as a tranquilizer, and the earlysettlers found that it was a good substitute for the garden heliotrope(Valerian) that women and children had used as a sedative in Europe. They beganto refer to the plant as American Valerian, and by the mid-nineteenth century,doctors were prescribing the root for hysteria, delirium, irritability,epilepsy and neuralgia. Although called American Valerian, because of itscalming properties, Lady's Slipper is less potent than Valerian, and the rootsof several varieties of this plant (Cypridedium pubescens/ larger and Cypridediumparviflorum/ smaller) were included in the United States Pharmacopoeiafrom 1863 to 1916. Lady's Slipper is a complex resinoid substance andincludes cypridenin.

Medical Uses:

Lady'sSlipper is mainly used as a nervine and tonic that gently strengthens thefunctional activity of the nervous system. As such, it has been used bygenerations to relieve hysteria, general nervousness, delirium tremens,tension, anxiety, nervous depression, irritability, recurring headaches and arelief for all stress. Its relaxing qualities are also considered helpful forreducing hyperactivity in children.

As a mild sedative,Lady's Slipper is said to be effective in easing chronic insomnia and restlessnessand is especially useful during those times when "the brain just won'tshut off," and it allows sleep. Lady's Slipper is considered superiorbecause it is non-narcotic.

Lady's Slipper isconsidered an antispasmodic and has been helpful for relieving cramps andmuscle twitches and spasms. With its additional ability to relieve nervousconditions, it has also been used in the past to ease epilepsy.

Lady's Slipper helps torelieve neuralgia, which is a severe, throbbing or stabbing pain along the courseof a nerve. It is also thought to be useful in relieving Bell's Palsy.

As a diaphoretic,Lady's Slipper is said to increase perspiration, which ultimately cools thebody and eases intermittent fevers.

E.P.W.B.C. - Empowering People With Breast Cancer: Staying Healthy and Healing The Body Naturally: He...

2011-12-27T22:05:00.000-05:00

E.P.W.B.C. - Empowering People With Breast Cancer: Staying Healthy and Healing The Body Naturally: He...: Staying Healthy and Healing The Body Naturally: Healthy Recipe : Chipotle and Orange Grilled Chicken Recipe Quick Info: ...

Children with Severe Epilepsy Have Experiences Side Effects From EEG's

2011-12-21T08:11:00.003-05:00

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According to an investigation led by Dr. Thomas Blauwblomme and his team of Great Ormond Street Hospital, London, in the December issue of Operative Neurosurgery, a quarterly supplement to Neurosurgery, official journal of the Congress of Neurological Surgeons, almost half of all children suffering with severe epilepsy who receive invasive electroencephalography (EEG) recordings, experience some type of side effect.

The study reveals that no other method can obtain the vital information needed for planning complicated epilepsy procedures that EEG recordings provide.

Risks of Invasive EEG in Children?

The team examined side effects associated to invasive EEG recordings in 95 children between 1994 and 2009. The majority of epilepsy cases in children can be controlled with drugs, although surgery is highly effective when medications are not successful. In order to plan the surgery, surgeons need accurate information on the region of the brain which controls seizure activity.

EEG recordings are required in some complex cases to gather this information. EEG recordings use electrodes placed on the brain surface or into the brain tissues. The novel investigation set out to obtain detailed information regarding the risks connected with EEG recordings. In the study the children had extremely severe epilepsy, averaging over 200 seizures per month. The average age of the children was around 11 years.

The researchers discovered that in total, nearly half of the children (49%) experienced some form of side effect. Approximately 30% of children had more severe events that increased the time they were hospitalized. None of the adverse events caused permanent neurological damage or death.

Side effects included:

Infection - 15%
Brain swelling - 6%
Bleeding - 17%
Cerebrospinal fluid leakage - 11%

In most of the children who experienced bleeding and in some of those with infection, further surgery was required. After surgeons began using a novel type of graft material in 2002, no further problems with CSF leakage were reported.

Brain swelling was more prevalent among older children, while the complication rate was lower (20%) in children under the age of 2. Length of EEG recording, or if recordings used electrodes on the surface or implanted in the brain, was not associated with the risk of side effects.

In 69% of patients, EEG recordings successfully recorded the location of the seizure zone in brain activity during seizures. In total, 89% of children received surgery for epilepsy. The success rate of surgery was highest the more precise the invasive EEG recordings were in localizing the seizure zone.

The investigation notes the considerable risk of side effects associated to EEG recordings in children with the condition. Although the EEG is invasive, it provides "invaluable information" for locating the source of seizure activity within the brain.

The team highlight the relatively low risk of adverse events in children under 2 years - which adds to recent evidence backing early surgery for children with epilepsy that doesn't respond to drugs.

Dr. Blauwblomme and coauthors explain:

"For all children undergoing invasive EEG recordings, parents should receive detailed information on the risks and benefits of the procedure."

In addition, the researchers stress that the surgery should be performed at a treatment center with experience in invasive EEG recording, with cautious planning prior to the procedure and close patient follow-up afterward.

Superior Drug Combo For Difficult-To-Control Epilepsy

2011-12-21T08:06:00.002-05:00

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A combination of two common drugs, lamotrigine and valproate, is more effective in treating difficult-to control epilepsy than other anti-epileptic regimens, according to a University of Washington report published online this week in Neurology, the journal of the American Academy of Neurology.

More than 3 million Americans have epilepsy, and about one million of these have a difficult-to-treat form.

In a large-scale, retrospective study of a population of patients with very difficult-to-control epilepsy, researchers discovered that only the lamotrigine/valproate treatment regimen, out of the 32 drug combinations studied, significantly decreased seizure frequency in this group.

This specific combination reduced seizure frequency by about half, on average, compared to other regimens. Although it rarely produced complete freedom from seizures, the combination was superior to others in reducing the number of convulsive seizures patients experienced.

Dr. Nicholas P. Poolos, a University of Washington associate professor of neurology who practices at the UW Medicine Regional Epilepsy Center in Seattle, led the project team of pharmacists and a neurobiologist.

Poolos explained that most people with epilepsy have good control of seizures, which means that they have been seizure-free for at least 12 consecutive months. About one third of people with epilepsy are "medically refractory." They continue to have seizures, despite trying several drug combinations prescribed by their physicians.

Physicians have had little evidence to guide them on which drugs or drug combinations, from a multitude of possibilities, might be of most help for patients with difficult-to-treat epilepsy.

This long-standing clinical challenge was the impetus for Poolos and his team to conduct a major study, the first of its size and kind to look retrospectively at patients treated for refractory epilepsy. They went into the project with no assumptions about which regimens to test.

"Identifying any anti-epileptic drug regimen with superior efficacy in patients with refractory epilepsy would be a substantial advance," the researchers believed.

What made this study possible was the discovery of 30 years of epilepsy treatment records at two Washington state institutions for the developmentally disabled. At these institutions, the Fircrest Habilitation Center in Shoreline, Wash., and the Rainier Residential Habilitation Center in Buckley, Wash., nursing staff had been recording the occurrence of each convulsive seizure in their patients with epilepsy, along with records of each patient's dosing of anti-epileptic medications.

The researchers determined that out of 32 most frequently used combinations of anti-epileptic drugs, only the lamotrigine and valproate combination had superior efficacy, compared to an aggregate measure of other drug regimens to which the patients had been exposed, as well as head-to-head comparisons with other anti-epileptic drug combinations. The researchers looked at both older and newer generation drugs.

"The study results dispel the dogma that all drug treatments are equally ineffective for this patient population," Poolos said, "and provide evidence for future, prospective drug trials."

The researchers said that their findings reported this week on the superior efficacy of the combination should ideally be confirmed in a prospective study of patients with refractory epilepsy, preferably from the general population.

The researchers also were surprised to find that while concurrent use of two anti-epileptic drugs was more effective than a single drug alone, three drugs at a time offered no additional benefits. Limiting the combination to two may lessen side effects from taking more kinds of anti-epileptic drugs, without sacrificing efficacy.

Lacosamide - An Anti Seizure Drug

2011-12-18T19:38:00.001-05:00

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In 2009 the U.S. FDA (Federal Drug Administration) approved the use of lacosamide (Vimpat) for adjunctive therapy for partial-onset seizures in patients 17 years of age and older. Moreover, it approved an intravenous (IV) version of the drug when oral administration is not feasible in these same patients. It does not have an approval for its use in status epilepticus, seizure clusters or seizure emergencies. The drug was reviewed by the FDA for its use in diabetic neuropathic pain, but was not approved for this indication. Since that time, lacosamide has rapidly ascended the prescription drug market as a popular choice of medication for epilepsy. In this month’s column we explore this drug lacosamide (Vimpat).

Mechanisms

Similar to almost every other seizure medication currently approved, the mechanism of the antiseizure effect of lacosamide is not fully understood. It is believed that lacosamide impacts its antiseizure effect by enhancing sodium channel slow inactivation. Lacosamide reduces voltage gated sodium channel availability by selective enhancement of slow inactivation without interacting with fast inactivation of the same channel. Slow inactivation of sodium channels is a mechanism by which nerve cells (neurons) reduce electrical stimulation. Therefore, it helps to calm down abnormal excitability of nerve cells. Thus, lacosamide would have a similar yet distinct mechanism to other seizure medications, such as phenytoin, carbamazepine. It does not bind GABA or glutamate or calcium or potassium currents similar to other medications. It also does not have any special receptor binding that has been identified so this makes this agent a chemically different drug. In animal studies the use of lacosamide revealed protection against partial and generalized seizures in several animal models, particularly maximal electroshock induced seizures in mice and rats and hippocampal kindling models.

Pharmacokinetics

Oral lacosamide is bioavailable at 100%. Peak serum levels of the drug are reached one to five hours after oral administration and at the end of an IV dose. Food does not alter the rate or extent of Vimpat absorption. There is bioequivalence between a 200 mg oral version of the medication, as well as IV versions of medications given over 30 to 60 minutes. Lacosamide has low protein binding which has implications for patients on dialysis treatment. After a four hour dialysis session, 50% of the dose must be supplemented following hemodialysis. Lacosamide’s pharmacokinetic profile is linear from 100 to 800 mg dose, which means that as one increases the dose there is a proportional increase in the serum level of the drug in one’s system.

The half life of lacosamide is approximately 13 hours. Steady serum concentrations are reached after three days of twice daily dosing. The drug is eliminated by renal excretion. Forty percent (40%) of this drug is excreted renally as unchanged drug, and about 30% is excreted as a metabolite, and about 20% as an unknown metabolite as well. Its major breakdown product is chemically inactive.

Lacosamide levels increase in patients with mild or moderate renal impairment and in patients with severe renal impairment, one need to adjust the dose appropriately. In patients with liver disease, Vimpat levels may increase from 50 to 60% and therefore doses should be adjusted downward for individuals with mild or moderate liver impairment. In patients age 65 years and older there may be a slight increase in levels by 20% compared to younger patients, This means that lower doses of the medication are needed as compared to a younger aged adult.

Efficacy

The efficacy of lacosamide was established in three 12-week randomized, double-blind, multi-center studied enrolling adult patients. Patients enrolled in these studies exclusively had partial-onset seizures with or without secondary generalization that were not adequately controlled on one to three other antiepileptic drugs. The patient that would typically enroll in these trials tended to have somewhat severe epilepsy, with an average of four or more partial-onset seizures every 28 days, and no seizure-free period exceeding more than 21 days. The studies found that at its best, the median percentage reduction of seizure frequency was 35%; 37.3%; and 39% in the 3 studies. Fifty percent (50%) reduction seizure frequency was achieved in 33%-35% who received 200 mg of the pill; 38.3%-41% with those taking 400 mg. Although lacosamide was tested at doses higher than 400 mg, the FDA approved the drug up to a dose of 400 mg, due to the fact that higher doses produced more side effects than benefits.

IV lacosamide was also trialed in a randomized, double-blind study with 60 patients. The IV version of the drug was consistent with the oral drug and seizure rates were similar to what was observed with the oral form. The drug was infused over 30 minutes in 40 patients; 50 minutes in 100 patients; and 10 minute in 20 patients. Adverse reactions did not differ with varying administration times; however, the drug was approved to a maximum drug infusion of 300 mg over 30-60 minutes.

Side Effects

Lacosamide’s most common adverse effects include dizziness, ataxia or syncope. Dizziness occurred in 25% of patients receiving lacosamide as add-on therapy. Ataxia, or gait disturbance, was experienced by 6% who were receiving lacosamide. Dizziness and ataxia were observed while the drug was being initiated. Episodes of syncope were reported in individuals with diabetic neuropathy. There also appears to be no clear abnormalities related to psychiatric , mood or behavioral issues related to use of the medicationsThere is a small but measurable cardiac effect with the use of lacosamide. A dose-dependent PR interval prolongation has been observed in association with lacosamide. Caution is advised for patients who have a known cardiac conduction problem, such as first degree AV block, second degree or higher AV block, or sick sinus syndrome without a pacemaker. Patients with myocardial disease or heart failure and patients taking other drugs known to impact PR interval should obtain an EKG while taking this drug.

Lacosamide is considered a pregnancy category C drug. Teratogenic effects have not been observed in humans, however, lacosamide was associated with increased embryo, fetal, and perinatal mortality in growth, of rats following administration during pregnancy. Developmental neural toxicity was also observed following exposure during a period of postnatal development corresponding to a third trimester of a human pregnancy. Because Vimpat may have some impact on the CRNP- 2 receptor- an important receptor for fetal central nervous system development, potential adverse reactions on central nervous system development have not been ruled out. Lacosamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lacosamide and its metabolites are excreted in the milk of lactating rats. It is not known whether lacosamide is excreted in human milk. Thus, lacosamide should not be used in mothers who are breastfeeding.

Drug Interactions

Lacosamide does not induce hepatic enzymes. Therefore, lacosamide does not have any drug interactions associated with the use of other seizure medications. It does also not have any interactions with oral contraceptives, cardiac, antihypertensives, or antibiotics.

Dosing

Lacosamide therapy can be started orally at an initial dose of 50 mg twice daily. This can be increased based on tolerability by up to 100 mg per day in two divided doses on a daily basis. It is important to note that with lacosamide, the faster that one increases the dose of the drug the more likely one is to encounter side effects. This is important in older adults and other individuals who are sensitive to medication. Thus the adage of going “slow and low” when dosing the older adults is vital in order to maximize tolerability.

Lacosamide can be taken with or without food. Its maximum dosage should be 400 mg, although higher than 400 mg can be used if the physician feels that the benefits of the increased dose outweigh the risks of side effects.

Summary

Lacosamide is a unique medication for individuals with uncontrolled partial seizures. Its primary advantages include the fact that it has no drug interactions, is dosed twice a day, and it effective. The drug appears to work in a manner similar yet distinct to phenytoin and carbamazepine. The drug has an IV formulation, therefore it might be useful in emergency situations; but again, it has not been approved for use in this condition.

Superior Drug Combo For Difficult-To-Control Epilepsy

2011-12-17T10:53:00.001-05:00

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A More Ethical Way To Compare Epilepsy Treatments

2011-12-13T14:25:00.000-05:00

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Epilepsy drug-switching study shows that using more ethical control groups could be the way forward for testing both drug efficacy and safety

For the first time, a new research methodology recently approved by the Food and Drug Administration has been used to demonstrate that converting patients from one anti-epileptic drug to another - in this case, lamotrigine extended-release (LTG XR) - is well-tolerated, effective and safe. The work by Jacqueline French and her team, from New York University in the US, illustrates how the new methodology addresses ethical issues inherent in more traditional study designs. It is published online in Springer's journal, Neurotherapeutics.

The use of traditional control groups in experimental designs can raise some ethical concerns, such as using inferior treatments for the control group in the study of an illness with significant morbidity and mortality, such as epilepsy. What French and team have done is compare their intervention group - the one where they are moving patients from one drug to another - with a so-called 'historical control group' obtained from a dataset of eight previously published studies, rather than recruit a new control group and give them a potentially less effective drug.

In their study, a total of 226 patients aged 13 years or older undergoing treatment for epilepsy across seven countries were randomly allocated to one of two groups: the first group received LTG XR 250mg; the second received 300mg once daily. During the conversion phase (11-12 weeks), the LTG XR dose was increased progressively as the previous drug was withdrawn gradually. The subjects then had a 12-week maintenance phase with LTG XR as monotherapy. Throughout the study period, the researchers monitored both the type and frequency of seizures and compared them to pre-intervention assessments.

The results demonstrate that LTG XR is effective as monotherapy. Approximately half of the study participants experienced at least a 50 percent reduction in seizure frequency compared to the number recorded before the study. More than half the group reported minor adverse events, including headache and dizziness predominantly.

The authors conclude: "A conversion-to-monotherapy study like ours, which incorporates a historical control, provides important information to clinicians, who often wish to convert their patients from one anti-epileptic drug to another. Without putting a group of patients at undue risk of seizure worsening, we demonstrated that it is possible to convert patients from another drug to LTG XR and that this conversion is well tolerated."

'Breaking Dawn' Seizures Spark Warning

2011-12-12T08:05:00.001-05:00

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The Epilepsy Foundation of America is using Facebook to warn its 11,000 followers about the "Breaking Dawn" birth scene's seizure-inducing effects.

"If you have photosensitive seizures, it may be best for you to avoid seeing this movie,"

Not since the Pokemon incident of 1997, in which more than 700 Japanese cartoon viewers were hospitalized, have strobe-light-induced seizures garnered so much attention.

At least nine people have reported suffering seizures during the bloody scene that boasts flashing white light. Those flashes, at just the right frequency, can cause neurons in the brain to start firing in synch -- a deviation from their usual chaos.

"When the brain is functioning normally, there are neurons firing all over the place," said Dr. Dan Lowenstein, director of the University of California, San Francisco Epilepsy Center. "During a seizure, there's an abnormal synchronization that we don't usually have."

That synchrony, which starts in the visual part of the brain, can quickly spread, causing a seizure.

"We routinely flash lights in front of patients' eyes during electroencephalogram or EEG testing because it's known that sometimes flashing lights can trigger seizures," said Dr. Robert Laureno, chair of neurology at Washington Hospital Center in Washington, D.C.

Laureno, who said he was dragged to "Breaking Dawn" by his wife, was surprised to hear the scene had caused seizures.

"Personally, I don't even remember the flashing lights," he said. He does, however, remember the blood. In fact, his wife's friend, a nurse, had to help a fellow Twilight fan who fainted during the gory scene.

"It appears there's been all kinds of loss of consciousness associated with this movie," said Laureno.

The blood may even be causing the apparent seizures, according to Dr. Orrin Devinsky, director of the NYU Langone Comprehensive Epilepsy Center.

"For some people, fainting mimics seizures," said Devinsky. "And for a very small minority of people, fainting can induce a full-blown seizure."

In response to the Epilepsy Association's Facebook warning, one woman said her epileptic daughter felt nauseous during the scene. Other people with epilepsy said the scene didn't affect them at all.

People with epilepsy are particularly prone to seizures. For them, many things can trigger the abnormal brain firing, including fatigue, alcohol, infections and certain medications. In extremely rare cases, activities like math and reading as well as certain songs or voices have triggered seizures.

"I once saw a patient who only had seizures when he heard a particular Rod Stewart song," said Devinsky, although he couldn't remember the name of the song.

There was also a famous case of a woman who had seizures in response to "Entertainment Tonight" host Mary Hart's voice.

Devinsky, who saw "Breaking Dawn" with his daughters, was surprised to hear it may be inducing seizures.

Although they can be scary, isolated seizures are not typically dangerous unless the person falls. People prone to seizures should avoid the movie, according to the Epilepsy Foundation. And viewers who start to feel unwell during the birth scene should stay seated and cover their eyes with their hands or clothing.

"The retina is still sensitive to flashing light even with the eyelids closed," said Dr. Juliann Paolicchi, director of pediatric epilepsy at Vanderbilt University Medical Center.

Paolicchi said most movies steer clear of flashing frequencies known to spur seizures.

"The filmmakers may want to add a disclaimer or modify the flash frequency," she said.

But some flashing lights are hard to avoid.

"In spring and fall it's common for patients to have seizures while driving on the road because the sunlight flickers through the trees," said Paolicchi. Evenly-spaced reflective pylons can also trigger seizures, she said.

The New Epilepsy Medicine Clobazam

2011-12-12T07:53:00.001-05:00

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On October 24, 2011, the U.S. Federal Drug Administration announced that clobazam (Onfi) was approved for use in the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older. Clobazam is a benzodiazepine which belongs to the same family of drugs that includes lorazepam (Ativan) ,diazepam (Valium), midazolam (Versed) and clonazepam (Klonopin).

Clobazam is different from the other benzodiazepines because it is utilized for the long-term treatment of epilepsy due to its effectiveness and relatively low tendency to produce sedation. Outside of the United States, clobazam is one of the most commonly used anti-seizure medications in the world. It has been approved in several other countries, particularly Canada, Mexico and most of Europe. Because of this, the drug’s entry into the US comes with an extensive clinical experience that is often not seen with other recently approved agents.

Effectiveness

Clobazam is being marketed in the United States under the trade name of Onfi. The FDA indication for clobazam is strictly for add-on therapy for treatment of seizures associated with Lennox-Gastaut syndrome in children from age 2 and older. The effectiveness for this drug was established in 2 multi-center control studies done specifically to bring the drug to the U.S. market. Both studies were similar in terms of the patient populations that were studied. The first study was a randomized, double-blind, placebo-controlled study that looked at patients who were aged 2 to 54 years with a current or prior diagnosis of Lennox-Gastaut syndrome. The patients were divided into 2 groups by weight, those who were less than 30 kg and those who were greater than 30 kg, and then they were randomized to 1 of 3 maintenance doses of the medication (5 mg- Low, 10 mg Medium and 20 mg High doses). The primary measure for the study was the percent seizure reduction and weekly frequency of various seizures that typify the syndrome, primarily drop, tonic, or myoclonic seizures over a 4-week baseline to a 12-week period of observation on the medication.

In the low-dose group, there was a 41.2% reduction of total seizures. In the medium-dose group, there was a 49.4% reduction in seizures, and in the high-dose group, a 68.3% reduction. The placebo group showed only a 12.1% reduction. Because this is a drug in the benzodiazepine family, they also looked at the issue of tolerance which is common to this drug group. Tolerance is defined as whether a drug maintains its effectiveness over time at a given dose. In other benzodiazepines, one often needs to take more of a given drug in order to maintain effectiveness. There was no significant development of tolerance over a 3-month period of observation.

In the second major study, also a randomized double-blind comparison study of high- and low-dose Onfi consisting of patients aged 2-25 years with a current or prior diagnosis of Lennox-Gastaut, divided into 2 weight groups and then randomized to either a low target dose of 5 mg or 10 mg depending on whether they weighed more or less than 30 kg. In the high dose group, the target daily dose of 20 mg for less than 30 kg body weight vs. 40 mg for more than a 30 kg body weight. Results showed a significant reduction in seizure frequency in the high dose compared to the low dose group with a median percent seizure reduction of 93% vs. 29%. Based on these analyses, the drug was approved.

In other studies done outside of the US, clobazam has been found to be effective amongst almost all seizure types. However, excitement over these findings has been tempered by the fact that the benefits can often be short-lived. In one large Canadian clobazam cooperative study, more than 40% of patients with a single seizure type had a 50% or greater reduction in seizure frequency and 60% of patients with multiple seizure types had improvement in at least one type of seizures; however, side effects did occur with the most common being drowsiness.

Side Effects

The most commonly reported side effect with this drug includes tiredness and sedation. In general, these tend to be dose related with the higher doses resulting in higher reports of adverse effects. One needs to be careful about the use of this drug with other depressant drugs or alcohol. Also because it is a benzodiazepine, abrupt discontinuation should be avoided. This drug needs to be tapered slowly, otherwise withdrawal symptoms can occur. Withdrawal symptoms may include convulsions, hallucinations, behavioral disorder, tremor and anxiety. There is the chance of physical and psychological dependence on this drug. Similar to other seizure drugs, there is also the risk of suicidal thought or behaviors in patients who take this drug. The most common side effects that led to treatment stoppage in the control trials included lethargy, somnolence, ataxia, aggression, fatigue and insomnia. Other common side effects include gastrointestinal issues, decreased appetite and issues related to depression or psychiatric problems such as aggression or insomnia.

Pregnancy

Onfi or clobazam is a pregnancy Category C drug. There are no adequate or well controlled studies of Onfi in pregnant women and no adequate developmental toxicity studies of clobazam in animals. Onfi is excreted in human milk. The effects of this exposure on infants are unknown. The drug has not been utilized in children under the age of 2 and therefore caution is needed with addressing this group of individuals.

Drug Interactions

Onfi or clobazam is a weak inducer of the CYP3A4 isoenzyme. Some hormonal contraceptives are metabolized by this pathway; therefore, their effectiveness may be diminished when given this drug, so additional non-hormonal forms of contraception are recommended when using this drug. Dosage adjustment of Onfi can be necessary if administered with other strong inhibitors including fluconazole or ticlopidine or even omeprazole. Alcohol increases the maximal plasma [exposure] of clobazam by almost 50%, so it is not wise to take this drug with alcohol or other similar agents.

Clobazam can increase the peak levels of dextromethorphan. It can also decrease midazolam levels. It does not affect valproic acid or lamotrigine. Ketoconazole can increase clobazam levels. Fluconazole, ticlopidine and omeprazole can increase the levels of the active metabolite of clobazam, so one may need to adjust the dosage for those medications. Other medications such as valproic acid, phenobarbital, phenytoin, carbamazepine, felbamate and oxcarbazepine do not impact this drug.

Dosage and Administration

Onfi is available in a number of dose sizes. It should be started slowly in a divided dose twice daily, and it should be done according to body weight. Serum levels of clobazam and its metabolites require 5-9 days to reach a steady state level. Clobazam will be available in the United States as a 5 mg, 10 mg and 20 mg tablet for oral administration. The highest dose was 20 mg for less than 30 kg body weight and 40 mg for greater than 30 kg body weight.

How Does Clobazam Compare to Other Medications?

Because clobazam has been out in the world for a considerable amount of time, it is likely that this agent could be quite an important addition to the armamentarium for patients with epilepsy. Given that it is one of the most frequently utilized medications, it would not be surprising that this drug will be used popularly, given its indication is for a very difficult to manage population of individuals with epilepsy. Because Onfi is a benzodiazepine, one will have to be careful about the side effect of sedation and the possibility of tolerance. We will also have to be extraordinarily careful about counseling individuals to not suddenly stop this medication as it could lead to significant problems including seizure emergencies.

Brain Tumor and Seizures

2011-12-01T21:00:00.001-05:00

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Many people who have a brain tumor often experience a seizure. Though very scary, these seizures can be controlled with medication, lifestyle changes, or surgery.

It is estimated that 60 percent of brain tumor patients have a seizure at some point. In many cases, a seizure is the first sign of a brain tumor, and what leads to its diagnosis. Some people have just one seizure, while others have reoccurring seizures, a condition called epilepsy.

Brain Tumor Seizures: What Is a Seizure?

Seizures are sudden, convulsive attacks that are caused by a burst of electrical impulses in your brain. In people with brain tumors, the tumor itself can trigger seizures.

"The tumor is sitting there and sort of tickling the surrounding normal brain," says Elizabeth Gerstner, MD, assistant professor of neurology at Massachusetts General Hospital and instructor of neurology at Harvard Medical School in Boston. "The tumor is irritating the neurons that give rise to the seizure."

Brain Tumor Seizures: What Happens?

During a seizure, most people experience a range of uncontrollable reactions, which can include:

Muscle contractions
Jerking
Twitching
Tingling
Numbness
Staring
Ringing in the ears
Tongue biting
Chewing
Smacking of the lips
Perspiration
Dilation of the pupils
Confusion
Hallucinations
Incontinence
Shallow breathing
Unconsciousness

A person whose tumor has been removed can still experience a seizure. In that case, it’s not the tumor that is generating the seizure, but perhaps the surrounding tissue.

The Odds of Having a Brain Tumor Seizure

All types of brain tumors can produce seizures. However, some types are more prone to them:

Ganglioglioma. About 90 percent of people with this type of tumor, which is generally slow-growing, experience seizures.

Low-grade glioma. This is a rare cancer. Glioma starts in the brain’s glial cells, which are important in supporting brain tissue. Low-grade means that, at diagnosis, the cancer isn’t extremely dangerous. Between 60 and 85 percent of people with low-grade glioma experience a seizure.

High-grade glioma. Patients with this type of glioma typically live for about a year after diagnosis. More than half, 54 to 69 percent, will have seizures.

Glioblastoma and meningioma. Fewer than half of patients with these types of cancers will experience seizures.

Preventing Brain Tumor-Related Seizures

Anti-seizure medications are available and may help prevent future seizures. Your doctor may put you on these medications, which are also called anti-epileptic or anti-convulsive medications, if you have had a seizure or if you are at high risk of having one. The newer medications have fewer side effects.

Sometimes, the pressure that builds up in your brain because of a brain tumor can result in seizures. If this is the case, a treatment to relieve brain pressure, such as the placement of a shunt, can help prevent seizures. Steroids can also be used to control brain swelling and reduce the risk of seizures.

Brain Tumor Seizures: Safety Tips

If you are at risk for seizures, there are a number of precautions you should take to keep yourself and people around you safe in the event that you have another seizure.

Do not drive. Since seizures come on suddenly, if you are at risk of having a seizure, your doctor may tell you not to drive a car or other motor vehicle.
Take showers instead of baths. Older children and adults should take a shower with the bathroom door unlocked. Children should not be allowed to bathe alone.
Do not swim alone. Unsupervised swimming should not be allowed, and an adult capable of getting a seizing patient out of a pool should always be present.
Stay away from hot and sharp objects. Do not use power tools or electric knives. Put a guard around a fireplace or heater. Use a microwave instead of a stove.
Wear a helmet. If participating in sports, like biking or rollerblading, always wear a helmet.
Cover sharp corners. Cover sharp corners of tables and counters, much as you would do if you were baby-proofing your home.
Remain accessible. Do not lock yourself into a room where people will be unable to reach you. Instead, consider using a "do not disturb" sign.
Train your caregiver. Your medical team can talk with your caregiver about how to handle seizures if they do occur.

Caregiver Tips: What to Do During a Seizure

If your loved one, or person you are caring for, has a seizure:

Stay with them until the seizure is over.
Make sure they are breathing.
Lay them on their side.
Remove nearby objects that could cause harm.
Do not let them put anything in their mouth.
Protect their head from injury.

Seek immediate medical care if:

Injury occurs
They are struggling to breathe
The seizure lasts longer than five minutes
They have multiple seizures

Keep track of your seizures and talk with your doctor about when they occur and what may have brought them on. It may be that something, such as alcohol use, stress, or an illness, is triggering your seizures. If that is the case, lifestyle modifications or treatment may help.

Seizure Triggers and Precipitants

2011-12-01T20:57:00.001-05:00

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The immediate factors that provoke a given seizure are complex, and seizures are rarely predictable. Seizures may be triggered or irritated by a variety of mechanisms. The most common trigger is missed medication, whether intentionally or unintentionally. Sleep and wake cycles—and hormonal fluctuations—can also influence seizure frequency. Women are affected by pregnancy and menstrual cycles.

Excessive use and withdrawal from alcohol or drugs may trigger seizures, as can illness or fever. Adding or removing prescription medications or supplements can trigger seizures, and should therefore be done gradually.

Some studies indicate that emotional stressors such as worry, anxiety and anger may cause seizures, especially if combined with fatigue or chronic sleep loss. Practicing relaxation techniques and treating disorders contributing to sleep loss (such as sleep apnea) may decrease seizure frequency. Melatonin has been successfully given for sleep loss in children. Unpredictable changes in metabolic factors, such as vomiting, diarrhea and physical stress, can also contribute to seizures.

In contrast, reflex epilepsy is a condition in which seizures can be provoked by an external stimulus (flashing lights) or, occasionally, by an internal mental process (mathematical calculation). Reflex seizures are fairly predictable in response to specific stimuli, and may coexist with spontaneously occurring seizures. They are epileptic, not psychogenic, and may occur as either focal-onset or primary generalized seizures. An EEG response to repetitive light stimulation is called "photosensitivity," and is seen in about 25 percent of individuals with primary generalized epilepsy.

Reflex epilepsy usually begins in childhood and may be outgrown by adulthood. Triggers in pattern-sensitive epilepsy may include circles, stripes or other patterns, usually of high contrast. TV and electronic screen games have cause reflex seizures. This may be due to the flicker frequency of the screen and distance from it, as well as images. European TV has a lower flicker frequency and is therefore more apt to trigger seizures. Individuals who experience their first seizure while playing electronic screen games are found to be photosensitive.

Other types of sensory stimuli, such as light touch, tapping or soaking in hot water, can be associated with reflex seizures; auditory stimuli are less common triggers of seizures. Another type of reflex epilepsy that is even more intriguing and unusual is triggered by complex actions or mental processes. This includes primary reading epilepsy, seizures induced by thinking and eating-induced seizures.

For the most part, once triggers have been indentified, exposure can be limited, and that is the typical treatment, along with standard antiseizure medications.

Vascular Risk Linked to Long-Term Antiepileptic Drug Therapy

2011-12-01T20:50:00.001-05:00

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New research reveals that patients with epilepsy who were treated for extended periods with older generation antiepileptic drugs (AEDs) may be at increased risk for developing atherosclerosis, a common disorder known as hardening of the arteries. According to the findings now available in Epilepsia, the journal of the International League Against Epilepsy (ILAE), the vascular risk is significantly associated with the duration of AED monotherapy.

While the majority of epilepsy patients have good results with treatment, more than 30% of patients continue to have seizures even with AED therapy. In these cases of refractory epilepsy, long-term or lifelong AED therapy is needed. Prolonged treatment can lead to diabetes, thyroid issues, psychiatric problems and adverse drug reactions. Prior studies suggest that older-generation AEDs such as phenytoin, carbamazepine, phenobarbital, and valproic acid may alter metabolic pathways, contributing to increased vascular risks.

Lead author, Dr. Yao-Chung Chuang from Kaohsiung Chang Gung Memorial Hospital in Taiwan, and colleagues compared the long-term impact of different categories of AED monotherapy on atherosclerosis development. The team recruited 160 adult patients with epilepsy who had received AED monotherapy for more than 2 years, along with 60 healthy controls. Ultrasonography was used to measure participants' common carotid artery (CCA) intima media thickness (IMT) -- a measurement used to assess the extent of atherosclerosis.

"Our study found patients with epilepsy who were under long-term monotherpy with phenytoin, carbamazepine and valproic acid displayed significantly increased CCA IMT measurements," said Dr. Chuang. "These altered circulatory markers from prolonged AED therapy may accelerate the atherosclerotic process." Analysis showed that CCA IMT is positively correlated with the duration of AED therapy.

Researchers also investigated specific vascular risk factors associated with the type of AED therapy. Epilepsy patients taking carbamazepine or phenytoin for long periods exhibited increased levels of cholesterol and of the amino acid, total homocysteine (tHcy), and lower levels of folate, all of which increase risk of adverse cardiovascular and cerebrovascular events. Patients who were treated with valproic acid displayed elevated levels of uric acid, tHcy, and thiobarbituric acid reactive substances (TBARS), increasing atherosclerosis risk which the authors believe is based on oxidative mechanisms.

The authors argue that drug choice should be carefully selected for epilepsy patients requiring long-term AED treatment, particularly in elderly or individuals at high-risk of vascular events. Dr. Chuang concluded, "Our findings suggest that newer AEDs, such as lamotrigine, may minimize metabolic disturbances, and therefore reduce the risk of atherosclerosis brought on by long-term AED therapy."

Herbal Medicines For Seizures and Epilepsy Treatment

2011-11-24T10:07:00.001-05:00

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Seizures are the tingling or twitching in small areas of the body, such as the face, or the loss of consciousness and uncontrolled jerks of the whole body. Recurrent seizures are called epilepsy. Seizures may affect only part of the brain, or be generalized, causing grand mal symptoms of headache, drowsiness, dizziness, and a feeling of discomfort or "aura," followed by unconsciousness, stiffening, or uncontrollable jerking of the body, or petit mal which usually affects children and can be difficult to detect since it may seem as if the child is just daydreaming. Occasionally they found one that seemed to help. Unfortunately, when we try these remedies today, they are hardly ever as effective as the medicines our doctor prescribes. Some even make us worse, either directly, by lowering our seizure threshold, or indirectly, by interacting with our prescription medications.

Seizurcs are caused by sudden, uncontrolled occurrences of elcctrical brain activity. They can be triggered by injury, infection, or disease, or there may be no obvious reason.

Recent studies have found that infant vaccines DTP (diphtheria/tetanus/pertussis) and MMR (measles/ mumps/rubella) can increase the risk of seizure. Chemicals found in aerosols, pesticides, paraffin fire fumes, diesel emissions, and solvents may also be triggers. Studies show a link between epilepsy and celiac disease, an allergy or intolerance to foods containing gluten, such as wheat, barley, rye, and oats.

Treatment

Naturopathy It is believed that avoiding certain drugs, chemicals, and foods can also help prevent attacks. Naturopaths suggest a well-balanced gluten-free diet, high in vitamins D and B6, as well as zinc, calcium, and magnesium, which have anticonvulsant properties, and the amino acid taurine, to help control seizures . Avoiding caffeine and moderating your alcohol intake may also be recommended.

Bach Flower Remedies Clematis for preventing the initial feeling of vagueness and Rescue Remedy during an attack may be suggested.

Osteopathy The light pressure used in cranial osteopathy has been found to help relieve symptoms.

Yoga, Aromatherapy, Meditation, and Biofeed-back Many seizures occur during times of stress and these therapies have been found to be beneficial relaxation and body awareness.

Should I get the doctor involved?

Take the information that you gather to your doctor. If you're having seizures or unacceptable side effects, tell the doctor how you feel (remember to take your seizure calendar) and ask whether there's some other treatment that is likely to help you. When you say that you've been investigating an herbal medicine, the doctor should be willing to hear you out. Doctors also are trying to get educated about herbal products, so the doctor may or may not have more information about that herb.

NYU Langone expert calls for awareness, research of sudden death in patients with epilepsy

2011-11-11T14:00:00.001-05:00

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Over time, epileptic seizures can lead to major health issues, including significant cognitive decline and even death, warns Orrin Devinsky, MD, professor, Departments of Neurology, Neurosurgery and Psychiatry at NYU Langone Medical Center. In a review article in the Nov. 10, 2011 issue of the New England Journal of Medicine, Devinsky addresses the magnitude of sudden, unexpected death in epilepsy (SUDEP) and offers guidance to patients, physicians and families of those with epilepsy about the risk factors, possible causes and interventional measures.

"Although most people with epilepsy live full and productive lives, doctors may too readily assure patients that seizures will never hurt the brain and are never fatal," writes Devinsky. "If patients are aware that seizures can be deadly, they may be more motivated to adhere to antiepileptic drug regimens and avoid lifestyle choices that increase the likelihood of them."

According to the article, SUDEP usually occurs in chronic, severe cases of epilepsy. But it is estimated that 2.7 million Americans suffer from some form of epilepsy and, even under specialized care, 25 percent of these patients fail to achieve adequate control of their seizures, making therapies less effective and requiring more intensive and comprehensive care than is available through a regular neurologist.

According to Devinsky, the rate of SUDEP increases with the duration and severity of epilepsy. While the exact mechanisms are not known, Devinsky identifies several risk factors associated with known cases of SUDEP, which includes a high prevalence of seizure just prior to an event, an impaired respiratory condition, slowing or shutting down of cerebral functions and cardiac events.

Devinsky points to a long-term cohort study conducted in Finland of 245 patients diagnosed with epilepsy as children – which found that SUDEP may have been responsible for 38 percent of the 60 deaths that occurred over the 40 year span. The overall incidence of SUDEP is likely underestimated, adds Devinsky, because of incomplete databases and the fact that the cause may not be appropriately identified by coroners, medical examiners and physicians who are unaware of the diagnostic criteria for SUDEP. A reduction in sudden deaths among patients with epilepsy may be achieved through:

Increased awareness by the general public and medical community
Improved prevention and treatments of epilepsy
Further development and use of devices that detect seizures and can alert caretakers
Improved understanding of the mechanisms of SUDEP
Conducting interventional trials to prevent the progression of life-threatening seizure to sudden death

###

Dr. Devinsky is the director of the Comprehensive Epilepsy Center at NYU Langone Medical Center, which is among the largest epilepsy centers in the United States, and designated a Level 4 Epilepsy Center by the National Association of Epilepsy Centers (NAEC). He received his BS and MS from Yale University, MD from Harvard Medical School and interned at Boston's Beth Israel Hospital. He completed neurology training at the New York Hospital-Cornell Medical Center and his epilepsy fellowship at the NIH. Devinsky's is widely published in peer reviewed journals , including the New England Journal of Medicine, Journal of Neuroscience, Journal of Neuroimaging, Journal of Neurosurgery, Epilepsy Currents and Nature. He has chaired several committees of the American Epilepsy Society and has served as a Board member and is active in the American Academy of Neurology and the Epilepsy Foundation. He is a reviewer for more than 30 journals and Co-Editor of Reviews in Neurological Diseases, Epilepsy and Behavior, and Epilepsy.com. You can learn more at http://epilepsy.med.nyu.edu/.

About NYU Langone Medical Center

NYU Langone Medical Center, a world-class, patient-centered, integrated, academic medical center, is one on the nation's premier centers for excellence in clinical care, biomedical research and medical education. Located in the heart of Manhattan, NYU Langone is composed of three hospitals – Tisch Hospital, its flagship acute care facility; the Rusk Institute of Rehabilitation Medicine, the world's first university-affiliated facility devoted entirely to rehabilitation medicine; and the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to http://www.NYULMC.org.

Computer Programs Reveal That Differing Structures Underlie Differing Brain Rhythms In Healthy And Ill

2011-11-07T07:07:00.001-05:00

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Virtual brains modeling epilepsy and schizophrenia display less complexity among functional connections, and other differences compared to healthy brain models, researchers at Case Western Reserve University School of Medicine report.

The researchers worked backward from brain rhythms - the oscillating patterns of electrical activity in the brain recorded on electroencephalograms - from both healthy and ill individuals.

These oscillations relate to the state of awareness. But, instead of seeking answers to how the rhythms emerge, the investigators built models that, when they reproduced the different neural activity patterns seen in real brains, revealed underlying structural differences among the healthy and ill.

Their work is published in the online journal PLoS Computational Biology.

"Our hypothesis is that healthy brains share features with the virtual healthy brains and unhealthy brains share features with virtual unhealthy brains," said Roberto Fernández Galán, a professor of neurosciences at Case Western Reserve School of Medicine. Galán has a background in physics, electrophysiology and computational neuroscience.

Galán worked with G. Karl Steinke, a former graduate student in Biomedical Engineering at Case School of Engineering, and now a researcher at Boston Scientific Neroumodulation.

After breaking down the oscillating patterns of brain activity collected from real EEGs and MEGs into a usable form, the researchers applied inverse calculations and reverse engineering to develop brain models they refer to as virtual brains.

The most striking difference they found is in the hierarchical networks of brain connections among the models of healthy and unhealthy brains, Galán said. "The more complex the network, the more normal the EEG pattern."

"A healthy brain network is similar to the airport network," he explained. "There are a small number of hubs with many connections to other airports and a large number of smaller airports with only a few connections." In the brain model, the airports are called nodes and in the healthy model, about 10 percent of nodes are hubs.

In the real brain, the prefrontal cortex, which is a center for complex thought, social behavior and more, is a hub. "It is thus reasonable to think that the functional connectivity of the prefrontal cortex is altered in pathologies like schizophrenia", said Galán.

Indeed, the network in the epileptic brain model is less complex than the healthy model and the network in the schizophrenia model is even less so. The result is that the dominance of the hubs falls off, which may be indicative of a neuropathology or mental illness, the researchers say.

Their analysis reveals that oscillating brain activity in the virtual models appear to emerge from interactions among neurons and not from so-called pacemakers, which some researchers hypothesize are specialized neurons generating different rhythms of activity in the brain.

This information, combined with finding that healthy brain rhythms are not homogeneously distributed across all virtual brain nodes, supports the idea that oscillations may be a mechanism linking perceptual information across sensory and associative areas of the brain, the researchers say.

Galán and Steinke also discovered that nodes receiving the greatest input produced the smallest fluctuations in activity in the healthy and epileptic brain models. But the inverse relationship was not seen in the schizophrenic model.

The researchers have made the computer programs that run their algorithms and simulations available free to clinicians and other investigators who want to test the predictions made by the models or to expand their own studies. They are included in the supplemental materials, along with technical instructions supplied with the paper.

EPILEPSY YOU'RE NOT ALONE: FDA Approves Onfi To Treat Severe Type Of Seizures

2011-11-07T06:49:00.000-05:00

EPILEPSY YOU'RE NOT ALONE: FDA Approves Onfi To Treat Severe Type Of Seizures

FDA Approves Onfi To Treat Severe Type Of Seizures

2011-11-07T06:46:00.000-05:00

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As of 21st Oct Onfi (clobazam) tablets are FDA (U.S. Food and Drug Administration) approved as an add on treatment for seizures caused by Lennox-Gastaut syndrome in adults and children aged 2 years and older. The disease effects fewer than 200,000 people in the United States so it was granted what as known as "orphan status". Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research was pleased with the approval :

"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures ...This is a difficult condition to treat, and it will be helpful to have an additional treatment option."

Lennox-Gastaut syndrome often starts around the age of four and can be caused by a number of issues which include brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions.

30 to 35 percent of patients have no apparent cause. Patients usually experience a wide variety of frequent seizures, including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks). Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral disturbances.

Onfi, was added to ongoing seizure medication, and its performance established in two multicenter controlled studies of patients 2 years of age and older. In each study, the drug was analysed for the degree of reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic seizures resulting in a fall or loss of posture) from the 4-week baseline period to a maintenance period. Both studies showed patients taking Onfi had improved seizure control when compared to those taking control treatment (placebo in one study and low-dose Onfi in the other study).

Onfi does have side effects though and when compared to those taking an inactive tablet (placebo) these included: somnolence, sedation, fever, drooling, constipation, cough, urinary tract infection, sleeplessness (insomnia), aggression, fatigue, upper respiratory tract infection, irritability, vomiting, problems swallowing (dysphagia), problems with coordination (ataxia), bronchitis, and pneumonia.

Antiepileptic drugs in general may increase the risk of suicidal thoughts or behaviors in a very small number of people taking the drug and Onfi also carries this caution. Patients prescribed antiepileptic drugs should be monitored for depression, suicidal thoughts or behavior, and unusual changes in mood or behavior.

Onfi may slow thinking and impair motor skills and it is therefore important that patients on the drug do not drive, operate heavy machinery, or engage in other dangerous activities until they become used to how the drug might affect them. Onfi can cause abuse and dependence. It has been categorized as a Schedule IV drug under the Controlled Substances Act. Onfi also should not be discontinued suddenly. Patients using the drug should talk with their health care professional about slowly stopping the drug to avoid withdrawal symptoms.

The FDA is requiring that a Medication Guide be given to patients and caregivers when Onfi is dispensed. The Medication Guide describes the risks and adverse reactions people should be mindful of when using the product.

Onfi is manufactured by Catalent Pharma Solutions LLC, Winchester, Ky., for Lundbeck Inc. of Deefield, Ill.

Written by Rupert Shepherd

Drug Prevents Cerebral Cavernous Malformation In Mice; Could Replace Surgery

2011-11-07T06:42:00.001-05:00

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A drug treatment has been proven to prevent lesions from cerebral cavernous malformation - a brain blood vessel abnormality that can cause bleeding, epilepsy and stroke - for the first time in a new study.

The drug fasudil, which prevented the formation of lesions in a genetic mouse model of the disease, shows potential as a valuable new tool in addressing a clinical problem that is currently treatable only with complex surgery.

"The results are very exciting because they represent the first-ever evidence of a drug effect on the development of cavernous angiomas in living animals," said Issam Awad, MD, professor of surgery at the University of Chicago Medical Center and senior author of the study appearing in the journal Stroke. "The result was very dramatic. The prevalence of lesions went down significantly, and the lesions that developed in the mice were simpler and smaller and did not show any inflammation or bleeding."

Cerebral cavernous malformation (CCM), also known as cavernous angioma, occurs when small blood vessels of the brain grow abnormally large and irregular. The walls of these blood vessels can become stretched and thin, occasionally leaking blood into the brain and leading to hemorrhages, seizures, vision or hearing problems, and strokes.

CCM is estimated to occur in one out of 200 people, though the lesions may not always cause symptoms. Currently, when a CCM lesion is detected in an MRI of a patient, the only option is to wait and see whether it grows large enough to require brain surgery, Awad said.

"There is currently no treatment in clinical use to either prevent the formation or the maturation of these lesions," Awad said. "The way we deal with them now is we wait until a lesion gets bad or does something bad, and then we take it out."

Roughly one-third of CCM cases result from hereditary, familial forms of the disease, the most common of which was traced to a gene called CCM1 or KRIT1. By reducing this gene's activity, Awad's team in Chicago and geneticist Douglas A. Marchuk's team at Duke University successfully created CCM lesions in living mice. This model replicated familial CCM and allowed the testing of new treatments to prevent or reverse lesions.

In a parallel collaboration with Mark H. Ginsberg's group at the University of California, San Diego, the researchers proved that knocking down the CCM1 gene resulted in elevated activity of a signal called ROCK, which can make brain blood vessels "leaky." Further studies found that CCM lesion tissues resected from human patients and the mouse model also exhibited abnormally high ROCK activity. In light of these results, the researchers at the three institutions hypothesized that treatment with a drug inhibitor of ROCK might prevent CCM lesions from forming and rupturing.

Fasudil is the only specific ROCK inhibitor drug available for animal studies and human use, and has been tested for treatment of conditions such as angina and pulmonary hypertension. In the Stroke paper, first author David McDonald and colleagues tested whether a long-term treatment with fasudil could prevent lesion formation in CCM model mice.

After four months of treatment, genetically modified mice given fasudil displayed fewer and less severe lesions and fewer signs of hemorrhage and inflammation than similar mice given placebo treatment.

"This animal model and humans have lesions that are aggressive and symptomatic: They leak blood, they show inflammatory properties, and endothelial cells multiply or proliferate," Awad said. "None of these features were present in the fasudil-treated mice. It was like the lesion was chilled down and shrunk."

Fasudil is approved for clinical use in Japan for the treatment of a condition called cerebral vasospasm after aneurysm rupture, and it has been clinically well tolerated for that indication. In the U.S., the drug is not currently approved but has been tested in clinical trials for angina and pulmonary hypertension. If future experiments continue to support its effectiveness in CCM, Awad and colleagues hope to work with the drug manufacturers and the United States Food and Drug Administration to move this therapy to human clinical trials.

"This treatment approach will require validation and optimization in additional experiments before initiation of clinical trials; nevertheless, no other drug has ever before been shown to prevent lesion development, and this effect appears very promising," Awad said. "Our collaborative group is uniquely positioned with tools in hand to help develop this therapy."

Awad and colleagues are also hopeful that fasudil treatment might benefit sporadic forms of CCM, where they have detected increased ROCK activity. In the meantime, the fasudil results in mice offer hope that neurologists may soon have a preventative treatment that can ease the worries of patients with familial CCM.

"This treatment does not cure the disease," Awad said. "But if it is successfully translated to human therapy, it would be a bit like treating multiple sclerosis, where many treatments do not eliminate the primary disease trigger, but can muffle it, slow it down and make it not as serious, and therefore allow a patient to effectively live with the disease, as opposed to having the disease dictate their health."

Unhealthy Habits You Need To Break

2011-11-01T07:06:00.004-04:00

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Unhealthy habits can start to develop after many years of neglecting your body, without you ever realizing it. Look over the list carefully, and start planning for your future by putting a stop to these unhealthy habits:

10. Not setting aside time to exercise

Most people barely have any time for sleep, let alone exercise. Living a sedentary lifestyle with little to no exercise can lead to serious health conditions like stroke or arthritis. For adults, better health practices include 30 minutes per day of physical activity. This doesn't have to be done all at once. For example, think about doing a 10 minute walk during the day, and 20 minutes of light weight lifting or cardio when you get home. There are even exercises that can be performed when you're at work or while you travel.

9. Drinking your calories

Many people prefer drinking any other type of beverage aside from water. Companies have even gone to great lengths to entice people to drink water by creating flavored water. The fact of the matter is these people are drinking their daily allowance for calories away. What about diet soda and other diet beverages that use artificial sweeteners? Diet drinks are fine, until you are unable to find one, and resort to a non-diet drink like regular cola because you still can't stand the taste of water.

8. Having too much junk food

An addiction to junk food is just something that gets harder and harder to avoid as people get older. With less and less time on your hands, it's easier to get a hold of food that's really bad for you as opposed to something healthy. Fast food, vending machines and microwave meals can satisfy your hunger pangs, but they are also filled with foods high in calories and sodium that can lead to health complications like heart disease and too much "bad" cholesterol, also known as HDL cholesterol.

7. Eating in front of the TV

Eating junk food is one problem, but doing it in front of the television just compounds the issue and can lead to obesity and other health complications. The main issues with eating in front of the TV are:

You are so distracted that you don't know when to stop stuffing your face and end up eating more than you actually require. How many times have you eaten an entire bag of chips or popcorn while watching a movie or sporting event without even realizing it?

Every time you eat in front of the TV, you develop a tendency to always have something to eat while you watch. That means every time you want to watch your favorite movie or program, you're more inclined to bring something to munch on, even if you're not hungry.

6. Abnormal sleeping patterns

Skipping even one hour of sleep per day can have drastic effects on your health. When you're constantly tired, you are more prone to accidents, and you run the risk of developing:

Insomnia
Heart disease
Stroke
Hypertension

Studies have also shown a correlation between type 2 diabetes and too much sleep due to a disruption in blood sugar levels. That means you'll want to aim at eight hours per day; no more, no less.

5. Caffeine addiction

An occasional cup of coffee can actually be very beneficial to your health, but an addiction to caffeine is a whole other story. Too much caffeine can affect your regular sleeping pattern and can lead to high levels of stress.

4. Ignoring your nutrition

If you've developed some of the previous unhealthy habits, then you've probably been ignoring your nutrition as well. If you aren't supplying your body with the right amount of vitamins and nutrients, you are putting yourself at risk for developing severe health complications.

3. Too much time in front of the TV

Spending too much time in front of the TV creates a sedentary lifestyle. This makes you lazy, and less likely to get up and exercise. Pair that with the bad habit of eating in front of the TV, and you've got yourself a double dose of trouble. If you need your TV time, then try doing something productive while you watch like running on the treadmill or some other type of exercise.

2. Going overboard on the alcohol

Alcohol is something that's meant to be consumed in moderation, not every time you have a bad, or good, day at the office. Many people tend to overlook the dangers of alcoholism and excessive drinking. Some of the potential health risks of excessive drinking include:

Liver disease
Hepatitis
Depression
Anxiety
Dementia
Stroke
Liver cancer
Colon cancer
Breast cancer

1. Smoking

The worst of all these unhealthy habits on this list is smoking. Not only is smoking one of the leading causes of death, it can also lead to:

Increased risk of heart disease and stroke
Lung cancer
Increased risk of chronic bronchitis
Leukemia
Kidney cancer
Cancer of the larynx
Stomach cancer
Cancer of the uterus
Infertility
Stillbirth
Cancer of the throat
Oral cancer

With so many health risks associated with smoking, it's a mystery as to why people don't quit this unhealthy habit sooner.

The Bottom Line

The worst thing about this list is all of these unhealthy habits are, somehow, interconnected:

Not getting enough sleep creates a dependency on caffeine to function throughout the day. This leads to a caffeine addiction that can lead to sleeping disorders.
Spending too much time in front of the TV leads to spending less time exercising. If a person enjoys eating in front of the TV, more TV time means more eating, and in most cases, the type of food being eaten is junk food.
If a person drinks too much, they are drinking their calories. Heavy drinking is commonly associated with eating junk food, smoking and a complete disregard for proper nutrition.

By breaking these unhealthy habits, you are not only improving yourself, but you are also making a lifestyle change for the better.

FDA Approves Onfi To Treat Severe Type Of Seizures

2011-10-29T19:59:00.001-04:00

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"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures ...This is a difficult condition to treat, and it will be helpful to have an additional treatment option."

Epilepsy Surgery Helped Half Stay Seizure Free For At Least Ten Years

2011-10-18T21:01:00.002-04:00

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According to a report in this week's surgery special issue of The Lancet, approximately half of all patients who had undergone surgery for epilepsy remain seizure free after 10 years. Although, there is room for more improvement regarding pre-surgical evaluation and surgical treatment for individuals with chronic epilepsy. The article is written by Jane de Tisi, Dr Gail S Bel, and Professor John Duncan, National Hospital for Neurosurgery, and Imperial College London, and team.

In the study, researchers determined the long-term outcome for adults who had undergone epilepsy surgery by establishing relapse and seizure remission patterns after surgery. The long-term outcome of surgery for epilepsy in 615 adults was examined (497 patients received anterior temporal resections, 40 extratemporal lesionectomies, 40 temporal lesionectomies, 20 extratemporal resections, 11 hemispherectomies, and 7 palliative procedures [corpus callosotomy, subpial transection]), with a median yearly follow-up of eight years.

Apart from simple partial seizures (SPS), they estimated that at 5 years after surgery 52% of patients remained seizure free, and at 10 years 47% of patients remained seizure free. Compared to patients who had anterior temporal resections, those who had extratemporal resections were two times as likely to have seizure recurrence. No difference was recorded for patients who received temporal lesionectomies from those who received anterior temporal lobe resection. Patients with simple partial seizures in the initial two years following temporal love surgery were two and half times more likely to suffer from subsequent seizures with decreased awareness compared to patients with no SPS. The longer a patient was seizure free the less likely they were to relapse, conversely, the longer seizures continued the less likely the patient went into remission. In 19% (18 out of 93 individuals), late remission was connected when they began a previously untried antiepileptic drug. 28% of individuals (104 of 365) seizure-free had stopped taking drugs at the latest follow-up.

They revealed that after epilepsy surgery, 40% of patients are completely seizure-free in the long-term, and a further 11% of patients only having SPS. However, even though 82% of patients were free from seizures or SPS for at least 1 year, this does not indicate cure. Not one patients epilepsy became significantly worse. The researchers explain that clinical practice should change in order to refer suitable patients for potential surgery sooner. Currently, surgery is only considered for focal epilepsy and only if drugs have not been effective in controlling the patient's seizures for more than two to three years. In order to more accurately identify patients who will benefit from surgery and to increase success rates, selection process and surgical methods need to be improved. They say that some previous investigations could have implied over-optimistic expectations.

The new discovery that simple partial seizures continuing in the initial first two years following surgery increases the probability of seizures recurring in patients in comparison to those completely seizure free has never been reported previously. This crucial finding may affect the decision to decrease or continue antiepileptic medications. However, the researchers found it interesting that the majority of the patients who were seizure free following surgery decided to continue taking an antiepileptic drug. No anticipated randomized trial is available of stopping or continuing these drugs following surgery, and patients' decisions making may be based on major factors, such as pregnancy or learning how to drive.

They explain that taking these drugs is not a bar to driving. The important thing is that patients remain seizure free for 12 months and continue to be free of seizures. If a single antieplieptic drug is taken during pregnancy there is a 2-3% risk of a major congenital malformation, if the women is seizure free after surgery and is thinking about getting pregnant, she might consider stopping the medication before conception.

The researchers conclude:

"For seizure outcome, surgery is successful for many individuals in whom antiepileptic drugs have not been effective, but further improvements need to be made to presurgical assessment to further increase rates of success."

In a joint comment, Dr Ahmed-Ramadan Sadek, and Professor William Peter Gray, Wessex Neurological Centre, Southampton University Hospitals NHS Trust and University of Southampton, UK, explain that the new data will be helpful for counselling epilepsy patients and guiding their physicians. They conclude:

"This study validates the long-term effectiveness of epilepsy surgery showing that over 50% of all patients are rendered continuously long-term seizure free; it also raises important questions and challenges. Are the benefits of seizure freedom apportioned equally to the continuous and later remission groups? Can selection and reselection strategies be further improved to optimise long-term seizure control? Finally, the median duration of epilepsy before surgery in this study was 20 years. In view of the long-term results of surgery shown, clinical practice needs to change with the early referral of appropriate patients."

Written by Grace Rattue

The Race of a Lifetime

2011-10-17T18:38:00.001-04:00

Donate Now	PRESS RELEASE OCTOBER 17, 2011 The Race of a Lifetime The Epilepsy Therapy Project Assembles a Team of 31 Runners to Participate in the Legendary Marine Corps Marathon

by Samantha Macher

Image by Cynr via FlickrWashington, D.C., October 17, 2011— Imagine a crisp fall day in rural Middleburg, Virginia. Leaves of red and orange dangling lithely from their branches, cool air rushing down the sidewalk, briskly sweeping away the heat of the long summer days, your feet pounding against the pavement as you finish the tenth mile of your marathon training—

Autumn has finally arrived in the Washington, D.C. area. Gone are the dog days of summer, as the season gives way to beautiful fall foliage, hayrides, pumpkin carving and… running?

For athletes all over the country, the changing of the leaves is as much a hallmark of “running season” as it is of colder weather. In October alone there are upwards of sixty marathon races that are available for runners to test their strength, endurance and fortitude nationwide. Among these races, however, one stands alone as a challenge for our nation’s soldiers and civilians alike: The world-famous Marine Corps Marathon.

This year, the Epilepsy Therapy Project, located in Middleburg, Virginia, is a Charity Partner with this legendary race. In an effort to raise awareness for epilepsy and the urgent need for new therapies, ETP has put together a team of thirty-one dedicated runners who have volunteered to lace up their sneakers to run the race of a lifetime. But their race began long before the marathon started. While training for the event, each member of Team ETP was charged with raising $1,000 to help fund epilepsy research, a goal most of the runners have far exceeded. In addition to raising awareness in our mission to accelerate new therapies, ETP also hopes to call attention to Traumatic Brain Injury (TBI), a leading cause of epilepsy and a common malady facing our soldiers overseas.

Colin Powell stated in his 2011 Memorial Day speech that over 400,000 soldiers will return from Iraq and Afghanistan with some form of TBI, making them twenty-nine times more likely to develop epilepsy in their lifetime. In America today, roughly one percent of the population has a form of epilepsy, and nearly one third of those individuals suffer from uncontrolled seizures. At the Epilepsy Therapy Project, our mission is to accelerate ideas into therapies for people living with epilepsy and seizures. By joining together with the Marine Corps Marathon, ETP hopes to honor our heroes by helping the ones who have suffered these types of injuries. As Kevin Malone, ETP board member and parent of a son who has epilepsy due to TBI said in his address to the Institute of Medicine, “We need to be a country and a people who do not let those who have experienced head trauma end up with a hellish life… Epilepsy takes freedom from those who suffer from it. We cannot allow our citizens who have fought for freedom to lose their own freedom.”

When ETP first began their search for participants over six months ago, they were pleasantly surprised by how many people from across the country, and even as far as Costa Rica, answered the call. Their runners are a diverse group made up of parents, children, friends, and soldiers, all of whom have lives affected by epilepsy. Though these individuals might have chosen to run for different reasons, they have banded together as Team ETP; running for better therapies and better lives for people living with epilepsy.

One participant, Brandy Bartley, is racing for someone dear to her heart. “I am running the Marine Corp. Marathon in honor of my daughter [who] has battled epilepsy for almost 15 years...” She writes. “Sometimes Halle would have as many as 80 to 100 seizures a day…” Brandy’s daughter, Halle, has undergone five neurosurgeries in her eighteen years, as well as a “Vagus nerve stimulator implant, both the Ketogenic and modified Atkins diet, and countless number of medications…” none of which have proven to be effective in her treatment. But still, Brandy persists. “We don't stop fighting for Halle. We raise money, we work hard, we do what it takes to get new medicines and new therapies because we owe that much to Halle! Halle deserves a fighting chance and so does everyone else that has had to endure a seizure!!” Surely, Brandy’s fighting spirit will carry her through to the finish line on October 30^th.

Another runner for Team ETP will show the world his strength during the marathon. “I had my first seizure when I was 17 …” Dylan Nelson tells epilepsy.com “[There] was a terrible fear that my that seizures would become a more frequent and scary part of my life. I've heard plenty of stories of people, including my dad, who have a few seizures in their teens that quickly spiral into seriously debilitating and constant bouts in their twenties and each of my seizures had come with fewer and fewer days in between.” Dylan began running a year ago in the hopes that it would improve his overall health and maybe even lower the number of seizures he was experiencing. “Since that day, I've run almost 600 miles, dropped 25 pounds, started graduate school, found a job I love, and haven't had another seizure.” While this isn’t the case for all people with epilepsy, Dylan’s is an inspiring story of perseverance in spite of incredible odds. “I am running the Marine Corps Marathon…because I want to challenge myself…and accomplish something that one year ago I would have never thought possible. More importantly, I want to raise awareness and money for those people who haven't been nearly as lucky as I have, people who need and deserve more recognition for their battle against epilepsy.” Excitedly, he concludes with an enthusiastic “Let's go run!”

Dave Scott, a seasoned marathon runner, will also be joining Team ETP and he is guaranteed to be a standout, even among 30,000 participants. “Dave will carry 3 ½ x 5 ft American flag the full 26.2 miles!” That is because Dave is not only a veteran runner, but he is a veteran of the United States Military as well. “At age 18, Dave enlisted in the US Navy to fellow in his father's footsteps as a Yeoman onboard an attack submarine.” This American hero, however, faced many struggles while following his chosen path. “…Dave's desire was denied when his physical revealed that he had recently discontinued use of medication for Petit Mal epilepsy.” But much like in his marathon experiences, his persistence paid off in the end. “Displaying true resiliency, Dave reenlisted five years later and successfully completed Navy boot camp… “ The Epilepsy Therapy Project is proud to have one of our soldiers run for them this year.

Training for a marathon takes months of painstaking discipline. Athletes run up to one hundred miles per week through blisters and fatigue, dedicating spare time and energy to preparing for those grueling twenty-six miles. Many go through three or more pairs of expensive sneakers before finding the one that carries them through their race. Some sustain injuries during the run after working for months to get there, and worse, some do not finish in spite of the most diligent efforts. Thankfully most, if not all, participants will have a community that supports them. That community picks them up when they fall, and encourages them always to try again. That community is invaluable for they are there to share in the runner’s joy when they finally do cross that finish line.

The struggle of the marathon runner is in many ways similar to the struggle to find effective epilepsy treatments. Like the training, it takes time, energy and passion. The people at ETP have dedicated our lives and livelihoods to “to make new therapies a reality for patients.” Like the sneakers, research and development can be expensive and take many tries before finding success. With help from our donors, ETP “provide[s] financial support… to promising new therapies, and invest[ing] in programs and platforms that can take time and costs out of new therapy development.” Like the runner, sometimes a therapy does not succeed no matter how much effort was expended. ETP will never give up. As co-founder and Chairman Warren Lammert says “The time is NOW…With your help, ETP can and will make those therapies a reality.” And finally, like the runner, ETP could not succeed without a community who supports them. The Epilepsy Therapy Project would like to thank their runners and all those who generously supported their outstanding efforts, along with NeuroTherapeutics Pharma, Inc., TeamEpilepsy.com, Sterling Foundation Management, and UCB, Inc., for sponsorship of the team and events surrounding the Marine Corps Marathon. ETP looks forward to the moment they share with all runners, friends and partners who have generously supported them when they finally cross their finish line with effective therapies for everyone with epilepsy.

Support TEAM ETP at the Marine Corps Marathon!

Become a part of our community: The Epilepsy Therapy Project is a 501(c) (3) non-profit organization whose mission is to accelerate ideas into therapies for people living with epilepsy and seizures. Founded in 2002 by a group of parents, distinguished physicians, and researchers, the Epilepsy Therapy Project supports the commercialization of new therapies through direct grants and investments in promising academic and commercial projects. For more information about epilepsy, epilepsy treatments, the epilepsy pipeline, and how to make a donation to ETP, please visit our website, www.epilepsy.com or call 540.687.8077.

Premature Birth May Increase Risk Of Epilepsy Later In Life

2011-10-11T22:29:00.000-04:00

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Premature Birth May Increase Risk Of Epilepsy Later In Life

Being born prematurely may increase your risk of developing epilepsy as an adult, according to a new study published in the October 4, 2011, issue of Neurology®, the medical journal of the American Academy of Neurology.

"We found a strong connection between preterm birth and risk of epilepsy and the risk appears to increase dramatically the earlier the birth occurs during pregnancy," said study author Casey Crump, MD, PhD, of Stanford University in Stanford, California. "More effective prevention of preterm birth is urgently needed to reduce the burden of epilepsy later in life."

For the study, 630,090 adults in Sweden ages 25 to 37 were followed for four years. Participants who developed epilepsy were identified through hospital records as well as monitoring prescriptions for drugs that treat epilepsy. Of the participants, 27,953 had been born prematurely and 922, or 0.15 percent of the total study participants, had been hospitalized for epilepsy during the study.

The study found adults who were born very preterm (23-31 weeks gestational age) were five times more likely to be hospitalized for epilepsy as an adult compared to those adults who were born full-term (37-42 weeks gestational age). Adults who were born between 32-34 weeks of pregnancy were almost twice as likely to be hospitalized for epilepsy and adults who were born between 35 and 36 weeks were one-and-a-half times as likely to be hospitalized for epilepsy compared to those born full-term. The results remained the same regardless of fetal growth, birth order or related disorders that may be associated with preterm birth.

"Other disorders were also more common in people born preterm, including cerebral palsy and other diseases of the central nervous system," said Crump. "It's possible that the association between preterm birth and epilepsy may be explained by a decreased flow of oxygen to the brain in the uterus during pregnancy that leads to preterm birth or abnormal brain development resulting from preterm birth itself."

This study was conducted at the Center for Primary Health Care Research at Lund University in Sweden and was supported by the National Institute of Child Health and Human Development, the Swedish Research Council, the Swedish Council for Working Life and Social Research, and the ALF project grant.

Disclosure By Drug Companies Of Results Of Clinical Trials Necessary, Even When They Won't Lead To A Product

2011-10-02T13:34:00.000-04:00

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Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research - even when product development is no longer being pursued, says a commentary co-authored by a leading UC Davis drug researcher published online in Science Translational Medicine.

In the commentary, titled "Disclosure of Clinical Trial Results When Product Development is Abandoned," Michael Rogawski, chair of the Department of Neurology in the UC Davis School of Medicine, says that far too little attention has been given to the failure to reveal study results for drugs or medical devices for which development has been terminated.

Rogawski, an international authority on the development of drugs for epilepsy, says companies most commonly stop development of an investigational drug when clinical trials fail to show evidence of efficacy or if unacceptable adverse events occur. However, in some cases development is terminated because regulatory agencies require additional studies and the company sponsoring the trial is unwilling to comply. Companies may also terminate a program because of a lack of resources or because of a "reevaluation of the market opportunity."

Many sponsors do publish the results of their clinical trials even when there are no plans to market the product being tested, but there is no legal requirement that they do so. With little incentive to devote resources to an abandoned project, publishing often goes by the wayside. In this situation "scientific information on the efficacy - or lack of efficacy - and safety - or lack of safety - of the investigational agents is not available to the research community, and the opportunity to learn from unsuccessful clinical trials is eliminated," Rogawski says.

For example, Rogawski says that it is assumed that the mouse models used to identify new drugs to treat epilepsy have high predictive value, because every marketed antiepileptic drug has demonstrated activity in the screening models. But "this assumption could be erroneous, because we do not know if there are drugs that were effective in the models but did not exhibit efficacy or had unacceptable side effects in clinical trials and were therefore terminated by their sponsors."

Similar concerns have been identified in psychiatric drug research, leading to the conclusion that "translational medicine cannot approach its full potential if negative drug developments are unpublished."

Commentary co-author Howard J. Federoff, a neuroscientist and dean of the School of Medicine of Georgetown University in Washington, D.C., said disclosing negative results from drug and device trials benefits everyone.

"Disclosing negative results from drug and device clinical trials benefits the entire scientific spectrum," Federoff says. "Such reporting would lead to greater patient safety, improve treatment research strategies, and allow a more efficient use of limited resources. The HHS has within its power the authority to require such reporting and doing so would positively impact health outcomes."

Rogawski says that in 2007 Congress enacted a law requiring clinical researchers to post the detailed results of most clinical trials on the publicly accessible ClinicalTrials.gov database, whose original purpose was to assist patients in finding clinical trials. However, there is a loophole in the law that allows sponsors to delay submission of the data until the drug or medical device is approved for marketing by the Food and Drug Administration (FDA). If the product is not approved, the clinical trial results do not need to be made public. Under the authority of the FDA Amendments Act of 2007, the National Institutes of Health (NIH) is considering regulations to require reporting of the results for any registered trial even those that do not lead to an FDA-approved product.

Patients participate in clinical trials for many reasons, Rogawski notes, including the desire to contribute to medical knowledge, help the sick and benefit humanity. If sponsors diminish the opportunity for society to benefit from the altruism of research subjects, this subverts an implicit moral contract between sponsors and study participants.

Federoff adds: "Transparency in data sharing of trial results for products whose development has been abandoned will further improve translational science, engender trust among study participants, and optimize resource allocations for the pursuit of the most promising new therapeutics."

Staying Healthy and Healing The Body Naturally: Foods to Fight Fatigue

2011-09-28T07:19:00.000-04:00

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2011-09-27T07:32:00.000-04:00

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New study finds potential therapy for tumour-associated epilepsy

2011-09-21T07:45:00.001-04:00

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Glioma, one of the most deadly and common types of brain tumor, is often associated with seizures, but the origins of these seizures and effective treatments for them have been elusive until now.

A team funded by the National Institutes of Health has found that human gliomas implanted in mice release excess levels of the brain chemical glutamate, over stimulating neurons near the tumor and triggering seizures.

The researchers also found that sulfasalazine, a drug on the market for treating certain inflammatory disorders, can reduce seizures in mice with glioma.

“Seizures are a frequent symptom of glioma and are often poorly controlled by epilepsy medications,” said Jane Fountain, Ph.D., a program director at NIH’s National Institute of Neurological Disorders and Stroke (NINDS).

“Understanding why the seizures occur and how to counteract them could help us substantially improve the quality of life for people with glioma,” she said.

Harald Sontheimer, Ph.D., a professor of neurobiology and director of the Center for Glial Biology in Medicine at the University of Alabama Birmingham (UAB) added: “People have assumed that tumours cause seizures by irritating the brain, but that really isn’t a scientific explanation.”

“We have now shown that the seizures are caused by glutamate release from the tumour,” he stated.

The findings have been published in Nature Medicine.

Disclaimer: Bioscholar is not intended to provide medical advice, diagnosis or treatment. The articles are based on peer reviewed research, and discoveries/products mentioned in the articles may not be approved by the regulatory bodies.

Neuropace device for epilepsy up for FDA approval

2011-09-21T07:42:00.000-04:00

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A small device to treat epilepsy was tested in Indianapolis, and it's now up for FDA approval. Neuropace is implanted in the brain to detect and defuse seizures.

Stephanie Tolle of Franklin Township routinely visits a team of clinical trial doctors at IU Hospital to download data and get a tweak. It happens through a laptop, which views Stephanie's seizure activity via a trial device implanted in her brain.

"When electrical stimulation is applied, there is suppression. You no longer see the seizure after that," said Dr. Robert Worth, IU neurosurgeon.

Eyewitness News was there in operating room in August 2006 when Stephanie, with head shaved, became one of seven Hoosiers enrolled in the clinical trial to test the new Neuropace technology.

"The use of electrode to stimulate the brain and control seizures is brand new," said Dr. Worth.

Surgeons precisely implanted the thin wire with four electrodes deep in her brain where her brain-scarring seizures are generated. Once the guide wires were in place, they were attached to a transmitter. That was implanted into Stephanie's skull. Now, when it detects the beginning of a seizure, it will deliver an electronic charge to suppress it.

"Everybody is happy. Everyone is amazed at what its done for her and she is able to go and do more activities than she was before," said David Jones, Stephanie's partner.

She still can't drive, but Jones says her clusters of 16 seizures are now down to two to three in a four-day time period.

Published results show of the 171 patients nationally enrolled in the trial at 31 site, 47 percent experienced a 50 percent or greater reduction in their seizure frequency over 12 weeks of long term data.

"The longer the device is in place, the better the patients do," said Dr. Vicenta Salanova, Clarian Neuroscience.

The demand on the device means Stephanie is up for a second battery change.

"That is so easy compared to the brain surgery," she said.

It's an outpatient procedure set for early August.

The Neuropace trial is now closed. However, Clarian is now enrolling patients for a new National Institutes of Health sponsored trial called the ROSE trial. For further information call 1-800-210-7123 or 317-944-0184

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Everything You Want to Know About Lamotrigine (Lamictal)

2011-09-15T14:52:00.000-04:00

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Written by Dr. Joseph Sirven from
www.epilepsy.com

Lamotrigine or Lamictal is one of the most commonly utilized anti-seizure medications in the world. The drug which is considered a second-generation anti-epileptic drug was released in the 1990s and has become one of the more popular choices of medications for a broad variety of seizure and epilepsy types. The following column will help to answer questions that individuals may have regarding the use of lamotrigine or Lamictal in order to better educate individuals with regards to choices of anti-seizure drugs.

Chemistry and Mechanism of ActionLamotrigine is believed to work via a number of different mechanisms. Its primary mechanism is blockade of sodium channels in nerve cells. It blocks sodium channels activated from depolarized membrane potentials at lower concentrations than those required to elicit blockade from hyperpolarized membrane and occurs at clinically achievable concentrations. Lamotrigine produces a dose-dependent inhibition of high-voltage activated calcium currents possibly through inhibition of pre-synaptic N and P/Q-type calcium channels. Despite its apparent clinical activity in human absence seizures, it does not inhibit low voltage currents mediated by T-type calcium channels. Lamotrigine resembles the mechanisms of phenytoin, but there are striking differences between the two. Lamotrigine is twice as effective in inhibiting the release of glutamate as compared to GABA. Release of excitatory amino acid neurotransmitters such as glutamate and aspartate is blocked during sustained repetitive firing. Animal models also suggest that lamotrigine inhibits ischemia-induced release of excitatory neurotransmitters. Lastly, lamotrigine appears to display only modest inhibition of potassium channels and is a weak inhibitor of 5-HT uptake in humans.

PharmacologyLamotrigine or Lamictal is an orally administered drug and is available in a variety of dosage strengths including a dispersible tablet. There has been established similarity in the bioequivalence between these different varieties of Lamictal and lamotrigine. The drug is completely absorbed with the bioavailability of 98%. The peak serum concentration is achieved within 1 to 3 hours following oral administration. It has a linear oral absorption with proportionality observed following doses up to 700 mg. A secondary peak in serum concentration can occur 4-6 hours following either oral or IV administration. Food does not affect the absorption of lamotrigine.

An extended release formulation of lamotrigine is available. This formulation is coated and has a modified release core which allows for a gradual release of the medication over 12-15 hours. Studies in patients with epilepsy have demonstrated that the extended release formulation is equivalent to the immediate-release brand product when patients are converted from twice-daily dosing to once-daily dosing of the extended release.

Lamotrigine is systemically absorbed following rectal administration. It is also moderately bound to plasma proteins, about 56%. Lamotrigine’s half life is approximately 24-29 hours when the drug is given in monotherapy. Lamotrigine clearance however is higher in children and lower in the elderly as compared to young adults. Mean lamotrigine oral clearance and elimination half life were 0.64 and 32 hours respectively in children receiving monotherapy. Advancing age has a modest effect in increasing the half life in clearance, particularly in individuals 65 years and older.

Liver disease can influence the pharmacology of Lamictal. There are no significant differences in the clearance of lamotrigine in people who have chronic renal failure. About 17% of the dose of the drug may be removed by dialysis with a reduction in its half life to about 13 hours.

The clearance of lamotrigine does not appear to differ between men and women. Lamotrigine oral clearance can be increased during pregnancy with changes being most evident during the second and third trimester but returns to pre-pregnancy values during postpartum.

Lamotrigine apparent oral clearance may increase by as much as 150% during the second and third trimesters and there are indications that women treated with this agent may experience increased seizure frequency. Lamotrigine oral clearance appears to return to baseline values during the early post-partum period which will likely necessitate further dose modifications. These observations support the notion of monitoring lamotrigine serum concentrations both during pregnancy as well as post-partum.

A well-defined serum concentration effect for lamotrigine has yet to be conclusively established, but the target range of 4-14 has been suggested for patients with epilepsy.

Drug InteractionsLamotrigine displays substantial variability between patients with regards to its elimination from the body. Its half life is reduced by approximately 50%, about 12-15 hours in the presence of antiepileptic-inducing medications such as carbamazepine, Phenobarbital, primidone and phenytoin. There does not appear to be any significant interactions between lamotrigine and newer antiepileptic drugs such as topiramate, felbamate, gabapentin, pregabalin, zonisamide, vigabatrin and levetiracetam. Pharmacokinetic interactions between lacosamide and lamotrigine would not be expected. There have been modest reductions in the concentration of lamotrigine in patients who receive oxcarbazepine or Trileptal.

Because lamotrigine does not undergo enzyme-dependent metabolism, drugs that inhibit certain enzymes in the liver that affect lamotrigine can affect the concentration of the drug. Valproic acid can decrease lamotrigine’s clearance and it results in increased plasma concentrations. Valproic acid markedly reduces lamotrigine clearance and prolongs the half life to about 60 hours. Recent studies in adults have suggested that the maximal inhibition of lamotrigine clearance by valproic acid is approximately 65% with 50% of maximal inhibition occurring at valproic concentration of about 5-6 micrograms/mL. These studies suggest a valproic-mediated inhibition of lamotrigine begins at low valproic doses with maximal inhibition occurring at valproic doses of approximately 500 mg per day. While earlier studies suggested that concurrent treatment with lamotrigine m ay result in modestly decreased valproic serum concentration, this is unlikely to be important clinically.

Lamotrigine does not induce or inhibit cytochrome P450 isoenzymes. It is not extensively bound to plasma proteins. These properties would predict that lamotrigine have a low incidence of causing important pharmacokinetic interactions. Lamotrigine does not appear to significantly alter hormone concentrations in females who are taking oral contraceptives.

Daily doses of acetaminophen unexpectedly increase lamotrigine clearance. Occasional use of acetaminophen would not be expected to alter lamotrigine pharmacokinetics; however, prolonged dosage could. While Lamictal does not alter the pharmacokinetics of oral contraceptive medications, recent studies have suggested that treatment with lamotrigine and combined oral contraceptives may decrease lamotrigine serum concentrations. The addition of an oral contraceptive which contains ethinyl estradiol may decrease lamotrigine concentrations by as much as 50%. Importantly, this interaction dissipates quite rapidly during the pill-free week and within one week following discontinuation of an oral contraceptive agent.

Lamotrigine has the following FDA indications:

Partial seizures
Primary generalized tonic-clonic seizures
Generalized seizures of Lennox-Gastaut syndrome

The newer extended-release formulation is FDA approved as adjunctive treatment for partial seizures in patients greater than 13 years of age. In addition, lamotrigine is indicated for conversion to monotherapy in adults more than 16 years of age with partial seizures who are receiving treatment with carbamazepine, phenytoin, Phenobarbital, primidone, or valproic acid as a single background AED. To date, although data from several United States and European clinical trials suggest its usefulness, lamotrigine is not approved by the FDA as an initial monotherapy agent.

Effectiveness

Seven pre-marketing, multi-center, double-blind placebo-controlled add-on trials support the usefulness of Lamictal as adjunctive treatment for partial seizures in adults. The study with the highest dose demonstrated a mean reduction in seizure frequency of 36% compared to baseline. Seizure frequency was reduced by greater than 50% in about a quarter of these patients. More recently, a study found that once-daily extended-release lamotrigine was as effective as a combination therapy in patients 13 years and older with partial seizures, many of whom had failed multiple other AEDs. In this study, the percentage of patients with at least a 50% reduction in seizure frequency was significantly greater than placebo.

Although the lamotrigine is approved as a conversion to monotherapy, it is not approved as initial monotherapy treatment. Efficacy as a monotherapy in partial seizures has been shown by multicenter, double-blind randomized trials comparing 500 mg of lamotrigine to an active control of 1000 mg of valproic acid. Similarly, lamotrigine has been shown to have comparable effectiveness when compared to controlled-release carbamazepine in newly diagnosed older patients with epilepsy. A recently published SANAD trial, an unblinded, randomized effectiveness trial conducted in the United Kingdom suggested that lamotrigine was at least as effective as carbamazepine in patients with newly diagnosed partial seizures. Patients treated with lamotrigine were found to have a significantly longer time to treatment failure than either gabapentin or topiramate.

Lamotrigine does have an approval for generalized seizures in Lennox-Gastaut syndrome. A large, multi-center, double-blind, randomized add-on trial of lamotrigine demonstrated efficacy of lamotrigine for treatment of major motor seizures in children and young adults with Lennox-Gastaut syndrome. The target dose of lamotrigine was 15 mg/kg/patient not taking valproate, and 5 mg/kg for those taking valproic acid. Major motor seizures defined as atonic, tonic, major myoclonic, and tonic-clonic were reduced by 32% compared to baseline. Only a 9% reduction was seen in the placebo group. This led to its approval for Lennox-Gastaut syndrome major motor seizures.

Lamotrigine does not have an FDA approval for treatment of idiopathic generalized epilepsy; however, trials have suggested that lamotrigine may be effective for primary generalized epilepsy. Curiously, however, there is a belief that lamotrigine may actually exacerbate myoclonus. A small case series suggested that myoclonus may worsen with lamotrigine treatment in some patients with idiopathic generalized epilepsy.

Other Indications
Lamotrigine is indicated for the maintenance treatment of bipolar disorder to delay the time to occurrence of mood episodes such as depression, mania, hypomania in adults 18 years of age or older. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established. Further trials are ongoing to evaluate its usefulness.

Adverse Effects
Similar to efficacy, the safety profile of Lamictal has been defined by numerous clinical studies. The most important side effect has been rash. The mechanism for this rash is unknown, but it may be genetic. There is a cross-reactivity for rash with other anti-epileptic medication, especially carbamazepine and phenytoin. The incidence of serious rash associated with hospitalization, especially in pediatric patients was 0.8%. In adult populations, serious rash associated with lamotrigine occurred in 0.3%. In clinical trials in patients with bipolar disorders, there was a 0.08% rash rate. In general, the risk for serious rash appears to be increased when lamotrigine was either initiated at too high a dose or when dosage is rapidly increased.

With regards to comparison with other anti-epileptic drugs, there is no difference in rash rates between lamotrigine, carbamazepine and phenytoin. The most common side effects that are noted with lamotrigine include dizziness, some nausea, insomnia, tremor and rash. Several double-blind randomized studies indicate that lamotrigine may cause significantly less sedation than most other anti-epileptic drugs. Some studies have suggested that lamotrigine has a favorable psychotropic profile and may improve mood in some patients. This observation is confounded by increased sedation and improved concentration after converting from less well tolerated anti-epileptic drugs, but available evidence supports that lamotrigine can improve mood or even protect against adverse mood effects of other medications.

In summary, lamotrigine has been found to be a very popular drug primarily because it is one of the few broad-spectrum medications that can cover a number of seizures types and complex epilepsy conditions. The fact that it has been shown to be effective for a number of seizures explains why so many individuals have chosen to initiate this drug in their patients with epilepsy. The main adverse effect reported with the medication is that of rash and if one follows the slow titration escalation as suggested by the manufacturers of the drug, then one is less likely to see rash. However, that has been one of the difficulties in the use of this drug is that one has to give about 5 to 6 weeks of time in order to increase the dose of the drug to a therapeutic level.

More importantly is the fact that lamotrigine is a complicated drug to use with drugs such as Depakote where Depakote actually increases the chance of lamotrigine toxicity and therefore one has to be careful when adding lamotrigine to Depakote. Lastly, oral contraceptive agents that contain estrogen may lower the concentration of lamotrigine, so careful risk has to be taken with the use of this medication.

In women with epilepsy, lamotrigine has recently been found to have some effects that can occur in women who are exposed to the drug during their pregnancy. It is considered a Category C drug, which means that it may potentially lead to teratogenic effects in women exposed to this drug. The North American Anti-epileptic Drug Pregnancy Registry (NAAED) reported an unexpectedly high prevalence of isolated non-syndromic cleft palate and/or cleft lip in infants exposed to lamotrigine monotherapy during the first trimester of pregnancy. Because of this, lamotrigine has been assigned to pregnancy Category C by the FDA. Animal studies have revealed maternal toxicity and secondary fetal toxicity producing reduced fetal weight, delayed ossification and fetal death.

With regards to breast feeding, lamotrigine has been detected in human milk. Mild thrombocytosis is reported in the breast-fed infant. The manufacturer does not recommend breast feeding while taking lamotrigine.

In conclusion, lamotrigine continues to be a popular choice for physicians due to its favorable safety and effectiveness profile. It can cause problems such as rash, insomnia and it does improve mood. The negatives in the choice of this drug include the fact that it is slow to titrate and one must be very careful about its drug interactions with drugs such as valproic acid.

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