Â鶹´«Ã½Ó³»­

Â鶹´«Ã½Ó³»­

Explore the latest content from across our publications
Join The Â鶹´«Ã½Ó³»­

Log In

Forgot Password?
Create New Account

Loading... please wait

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, 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.
William E. Rosenfeld, MD, FÂ鶹´«Ã½Ó³»­ (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.