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Abstract Details

Dose Adjustments to Concomitant Antiseizure Medications: Post-hoc Analysis of a Phase 3, Open-Label Study of Cenobamate for Treatment of Uncontrolled Focal Seizures
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
005
This post-hoc analysis examined how dose adjustments to concomitant ASMs impacted tolerability and retention in an ongoing, phase 3 study (N=1347 enrolled) of adjunctive cenobamate.
Cenobamate is an FDA-approved ASM for uncontrolled focal seizures.
Patients on stable doses of 1-3 ASMs were enrolled. Dose increases of cenobamate (from 12.5 to 25, 50, 100, 150, 200 mg/day) occurred biweekly. Increases up to 400 mg/day by 50-mg/day increments biweekly and adjustments to concomitant ASMs were permitted.
Data from 240 patients were available; 177 remained on cenobamate (73.8% retention). For the majority of concomitant ASMs, ongoing cenobamate patients had greater decreases in mean concomitant ASM dose (first vs last dose) vs those who discontinued. Dose decreases were mostly due to adverse events, mainly during titration/early maintenance phases during cenobamate dose escalation. Phenytoin, clobazam, and lacosamide were decreased early and resulted in better retention. Among ongoing cenobamate patients, 98/395 (24.8%) concomitant baseline ASMs were discontinued completely, including carbamazepine in 31.3% of patients, oxcarbazepine in 26.7%, clobazam in 26.7%, lacosamide in 23.4%, eslicarbazepine in 23.1%, levetiracetam in 20.3%, and lamotrigine in 14.5%. Most patients in the efficacy analysis (N=240; median exposure 30.2 months) had significant reductions in seizure frequency across assessed focal seizure types. Responder rates over the maintenance phase (~27 months median duration) for the analysis population were 75.7% for ≥50% reduction, 57.5% for ≥75% reduction, and 13.6% for 100% reduction. High retention rates and numbers of seizure-free patients for prolonged periods (25.8% of analysis population and 33.9% of ongoing population had zero seizures for a mean 23.5 months at last visit) suggest efficacy of cenobamate.
In this post-hoc analysis, reducing doses of concomitant ASMs, across a range of drugs with various mechanisms of action, led to fewer cenobamate discontinuations. Decreasing doses of phenytoin, clobazam, and lacosamide occurred early compared to most other ASMs.
Authors/Disclosures
William E. Rosenfeld, MD, FÂ鶹´«Ã½Ó³»­ (Comprehensive Epilepsy Care Center for Children and Adults)
PRESENTER 		The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science.
Bassel W. Abou-Khalil, MD, FÂ鶹´«Ã½Ó³»­ (Vanderbilt University) The institution of Dr. Abou-Khalil has received research support from Cerevel. The institution of Dr. Abou-Khalil has received research support from Xenon. The institution of Dr. Abou-Khalil has received research support from Otsuka. The institution of Dr. Abou-Khalil has received research support from UCB. The institution of Dr. Abou-Khalil has received research support from SK LIfe Science. The institution of Dr. Abou-Khalil has received research support from Neuroelectrics.
Sami M. Aboumatar, MD (Austin Epilepsy Care Center) Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SK Life Science, Inc.. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion.
Perminder Bhatia, MD (Neuro-pain Medical Center Inc) Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIOHAVEN. Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ALLERGAN. Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SK LIFE SCIENCES.
Victor Biton, MD (AEP) Dr. Biton has nothing to disclose.
Pavel Klein, MD, FÂ鶹´«Ã½Ó³»­ (Mid-atlantic Epilepsy and Sleep Center) The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Sience. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alliance. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle Therapeutics. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aquestive. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Klein has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for PrevEp. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Fenwick . Dr. Klein has received research support from DOD/CURE.
Gregory Krauss, MD (Johns Hopkins University) Dr. Krauss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle. Dr. Krauss has received stock or an ownership interest from EpiWatch.
Michael R. Sperling, MD, FÂ鶹´«Ã½Ó³»­ (Thomas Jefferson University) Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medscape. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for International Medical Press. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Projects for Knowledge. The institution of Dr. Sperling has received research support from SK Life Science. The institution of Dr. Sperling has received research support from UCB Pharma . The institution of Dr. Sperling has received research support from Takeda. The institution of Dr. Sperling has received research support from Neurelis. The institution of Dr. Sperling has received research support from Engage Therapeutics . The institution of Dr. Sperling has received research support from Medtronic. The institution of Dr. Sperling has received research support from Cavion. The institution of Dr. Sperling has received research support from Xenon Pharma. The institution of Dr. Sperling has received research support from Cerevel. The institution of Dr. Sperling has received research support from National Institutes of Health . The institution of Dr. Sperling has received research support from DARPA. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Vice President with Epilepsy Consortium .
David G. Vossler, MD, FÂ鶹´«Ã½Ó³»­ (David G. Vossler MD FÂ鶹´«Ã½Ó³»­ FAES FACNS) Dr. Vossler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Longboard Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science. The institution of Dr. Vossler has received research support from Xenon Pharmaceuticals. The institution of Dr. Vossler has received research support from Longboard Pharmaceuticals. Dr. Vossler has received publishing royalties from a publication relating to health care.
Robert T. Wechsler, MD, PhD, FÂ鶹´«Ã½Ó³»­ (Consultants in Epilepsy & Neurology) The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Otsuka. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Science. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Engage. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eliem. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Epalex. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Equilibre. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rapport. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurona. Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurelis. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sunovion. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Greenwich/Jazz. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eisai. Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aquestive. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science. Dr. Wechsler has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Epilepsy Studies Consortium. Dr. Wechsler has a non-compensated relationship as a Board President with Epilepsy Foundation of Idaho that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.