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Abstract Details

Adjunctive Cenobamate Dose in Seizure-Free Patients by Baseline Seizures in the Phase 3 C021 Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
023
Assess whether baseline seizure frequency influenced the cenobamate dose required to achieve 100% seizure reduction in the open-label C021 study.

Cenobamate is approved in the US for treatment of focal (partial-onset) seizures in adults.

Adults 18-70 years old with uncontrolled focal seizures taking 1-3 ASMs received adjunctive cenobamate at a dose of 12.5 mg/day for 2 weeks, with increasing daily doses (25, 50, 100, 150, 200 mg) at 2-week intervals. A maximum of 400 mg/day (using biweekly increments of 50 mg/day) was permitted during a dose-optimization/maintenance phase.

Two hundred forty patients from 10 eligible US study sites were evaluated for the post-hoc analysis. In patients still receiving cenobamate (n=177), the mean duration of time on-study was 33.6 months, representing 495 patient-years of exposure, and the mean dose was 254.0 mg/day. Sixty (33.9%) patients had 100% seizure reduction for ≥12 months, with a mean duration of 23.5 months. The mean dose in these patients was 236.0 mg/day. Of these 60 patients, 40 (66.7%) experienced <3 seizures/28 days and 20 (33.3%) experienced ≥3 seizures/28 days at baseline. The mean dose in these patients was 226.4 and 255.1 mg/day, respectively. Decreases in seizure frequency during titration occurred with doses ≥12.5 mg/day in both groups. Most common adverse events were fatigue, dizziness, and somnolence. No cases of DRESS occurred.
One hundred percent seizure reduction for ≥12 months was achieved in 33.9% of patients still receiving cenobamate. The less intractable group with <3 seizures/28 days at baseline had a somewhat higher number of patients reaching 100% seizure reduction, with approximately 30 mg less cenobamate for their daily dosage, as opposed to those with ≥3 seizures/28 days at baseline. Both groups had decreases in seizure frequency early on (Weeks 1 to 2) during dose titration.
Authors/Disclosures
Sami M. Aboumatar, MD (Austin Epilepsy Care Center)
PRESENTER 		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.
Victor Biton, MD (AEP) Dr. Biton has nothing to disclose.
Robert T. Wechsler, MD, PhD, FAAN (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 AAN interests or activities.
William E. Rosenfeld, MD, FAAN (Comprehensive Epilepsy Care Center for Children and Adults) 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.