Pauline Anderson

December 05, 2014

Neurologists from around the world are descending on Seattle, Washington, not just for the fabulous seafood, spectacular waterfront, and innovative local vibe but to learn about the latest state-of-the-art research in epilepsy.

The more than 5000 researchers expected to attend the American Epilepsy Society (AES) 68th Annual Meeting on December 5 to 9 probably have their individual agendas, but some presentations, posters, lectures, and symposia promise to garner big interest.

Elson So, MD, AES president and professor of neurology, Mayo Clinic, Rochester, Minnesota, shared some studies and events that he thinks everyone should try to check out while staying in this West Coast city.

First is research on marijuana and epilepsy. There will be at least 5 related posters, including a late-breaking one on the potential efficacy of cannabidiol (CBD) for the treatment of refractory infantile spasms and Lennox-Gastaut syndrome. Researchers will provide results of an online survey of parents who shared their experiences of administering CBD products to their children with this devastating disease.

Dr So expects to hear much more detailed information from experts in the field about the role of medical marijuana in treating epilepsy. "There is more to it than what you have been hearing in the news," he said. 

Another meeting delegate — Michael Privitera, MD, professor, and director, Epilepsy Center, University of Cincinnati Neuroscience Institute in Ohio — said that emerging research in the field may not be as compelling as seen in initial anecdotal reports.

Preliminary data on medical marijuana as well as findings with Epidiolex, a 98% pure cannabidiol product produced by GW Pharmaceuticals, were actually released in advance of the meeting and reported by Medscape Medical News in October.

The results were still positive, although treatment was just perhaps not as beneficial as previously hoped. In the cannabidiol study, seizures decreased by 50% in about 30% of patients.

Various pharmaceutical companies are now moving forward with US Food and Drug Administration (FDA)–approved clinical trials of marijuana derivatives "in the way that real research should be conducted," said Dr Privitera.

Generic "Switches"

Another hot topic at the meeting will be generic drugs. Results of updated generic bioequivalence and therapeutic equivalence studies might verify that these drugs are as good as brand names and can therefore be "switched" in place of them. But then again, they may not.

"I am dying to know the results of these studies," said Dr So. "If as the AES president I don't know, that goes to show the scientific integrity of this research."

The controversial issue of whether generics are interchangeable with brand drugs has been brewing for some time. Before approving them, the FDA requires rigorous testing of generic formulations of antiepileptic drugs to assure bioequivalence to the brand product. However, physician surveys and case reports have suggested that not all generic formulations are equal to the brand drug for all patient groups.

A main concern is that the approved generic formulations, which are relatively inexpensive, may cause clinically significant changes in plasma drug concentrations. In patients with epilepsy, that could mean a big difference in seizure control.

Discussing SUDEP

Another area that should generate intense discussion is sudden unexpected death in epilepsy (SUDEP), a leading killer of patients with chronic, uncontrolled epilepsy.

It has been suggested that neurologists and others have widely varying comfort levels regarding initiating discussions on the topic with patients, even though research shows that most people with epilepsy want to hear about SUDEP from their neurologist, preferably at the time of diagnosis.

One study to be presented at the meeting addresses the uniformity of death certification surrounding SUDEP, which could affect estimated prevalence rates. A survey of medical examiners investigated the terms used to certify SUDEP deaths and looked to see whether they reflect any variation in coding.

From all accounts, however, SUDEP is uncommon, occurring in only about 1 in 1000 individuals with epilepsy each year.

Concerning Deaths

Dr So hopes that new research will help answer the question of whether patients with epilepsy who volunteer for research, and are assigned to take placebo, are more likely to die of SUDEP.

A meta-analysis published in Lancet Neurology in 2011 suggested this is the case, which, if true, is "concerning," said Dr So.

This analysis was recently repeated by the FDA using data it requested from the companies performing the trials. FDA representatives will appear at a "town hall" session during the meeting to discuss how the findings affect the design of add-on studies of antiepileptic drugs and what these findings mean for clinical practice.

Dr Privitera points out this research involved "thousands of patients in dozens of trials."

Dr So said he's "very pleased" that FDA leaders "have gone out of their way to reveal and discuss the results of their own investigations" on this topic at the meeting.

Detection Challenge

Yet another highlight will be revealing the results of the international seizure detection and prediction challenge, sponsored by the AES, the National Institute of Neurological Disorders and Stroke, and the Epilepsy Foundation. Hundreds of teams from around the world participated in the competition to come up with ways to quickly and accurately detect and predict seizure activity. 

Timely and reliable seizure detection is extremely important in epilepsy care. Being alerted to when a seizure is about to occur could reduce mortality and drastically improve quality of life for patients with epilepsy.

Neurostimulation could abort these seizures before they have a chance to affect a patient's normal activities. But for a neurostimulation device to stop a seizure, the seizure must first be detected and electrical stimulation applied as early as possible.

For the first phase of the competition, on seizure detection, contestants were charged with analyzing retrospective prolonged intracranial electroencephalography (EEG) data recorded from four dogs with naturally occurring epilepsy and from eight patients with medication-resistant seizures during an evaluation for epilepsy surgery. The research group that has identified the earliest EEG changes leading to seizures with the fewest false alarms will be awarded $8000.

For the second phase of the contest, on seizure prediction, researchers were to use the same dataset to try to predict seizures in advance of their clinical onset. The group that has predicted this with the highest accuracy will get $20,000.

The winners will be announced at the Presidential Symposium on Saturday, December 6.

Dr Privitera added that he will be checking out the annual course during which experts will debate when to get continuous EEG in the intensive care unit (ICU) to monitor for subclinical seizures and status epilepticus, and how best to treat them.

"This technique is not super new, but it's increasingly being applied to ICU patients, and so questions such as when to do it and what to do with the results are hot topics."

Among the many informative platform sessions will be a paper on factors influencing driving impairment, and another on a diagnostic blood test for epilepsy.

Dr So is also keen to promote the meeting's third annual wine tasting and silent auction. He urges delegates to join colleagues and friends to support the Susan S. Spencer Fund and the Lennox and Lombroso Trust. Tickets can be purchased at the registration desk. The event, according to Dr So, promises to "not only be exciting but a lot of fun."

And delegates might want to check out a poster that highlights the benefits of art therapy. Programs such as Studio E: Epilepsy Art Therapy Program cultivate a social and therapeutic opportunity for participants to create artwork in a variety of media. The Studio E program is available in almost 50 US cities, including Seattle, making it the first national program of its kind.

Some Poster Highlights

  • Abstract 1.326: Parental reporting of response to oral cannabis extracts as adjunctive treatment for medically refractory epilepsy (Craig Press et al)

  • Abstract 2.372: Potential efficacy of cannabidiol for treatment of refractory infantile spasms and Lennox-Gastaut syndrome (Raymond Zhou et al)

  • Abstract 2.405: Assessment of the anticonvulsant effects and tolerability profile of cannabidiol – GW Pharmaceutical's preclinical program (Nicholas Jones et al)

  • Abstract 2.065: SUDEP: What do patients want to know? (Rajesh Ramachandran Nair et al)

  • Abstract 2.070: A survey of medical examiner death certification of vignettes on death in epilepsy: gaps in identifying SUDEP (Daniel Atherton et al)

  • Abstract 2.142: SUDEP experience and practice in a large group of child neurologists (James Reese Jr, et al)

  • Abstract 3.321: The impact of an art therapy program on self-esteem and quality of life in people with epilepsy (Janice Buelow et al)

Other Highlights

  • President's Symposium; The AES International Biomarker Competition: The Crown, the Cloud, Detection and Prediction, Saturday, December 6, 8:30 am–11:45 am; Ballroom 6C

  • Third Annual Wine Tasting & Silent Auction: Saturday, December 6, 7–10 pm, 1927 3rd Avenue, Seattle (near the convention center)

  • Scientific Exhibit display: Equivalence among generic antiepileptic drugs: research funded by FDA, AES and Epilepsy Foundation (Equigen); Sunday, December 7, and Monday, December 8, 8 am–5 pm, Room 604

  • FDA Town Hall Update: SUDEP and Clinical Trials, Monday, December 8, 3–5 pm Room 612

  • Factors influencing driving impairment in persons with refractory epilepsy (V. Punia) Platform Session A.02 Monday, December 8, 3:15 pm, Room 608

  • A diagnostic blood test for epilepsy: a soluble ICAM-based panel (J.R. Pollard). Platform Session A.08, Monday, December 8, 4:45 pm, Room 608

  • Critical Care (ICU EEG monitoring): Controversies in ICU EEC interpretation and management; Tuesday, December 9, 7–- 8:30 am, Room 612

  • Hot Topics Symposium: Epilepsy Updates: Generic drug update (Dr Privitera). Tuesday, December 9, 9:40–10:05 am, Ballroom 6C

American Epilepsy Society (AES) 68th Annual Meeting, Seattle, December 5–9, 2014.

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