Abstract Details

Title Sustainability of Seizure Control With Adjunctive Cenobamate in the Phase 3 C021 Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P12 - Poster Session 12 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-001

Background Cenobamate is an antiseizure medication approved in the US for the treatment of adults with focal seizures.

Objective This post-hoc analysis was performed to determine how likely cenobamate-treated patients who achieved ≥50%, ≥75%, ≥90%, or 100% response would be to maintain that response after 1 and 2 years.

Design/Methods

Seizure data were collected from patient diaries and clinic notes from 10 US study sites participating in the phase 3, open-label, C021 safety study. Response was defined as reduction in 28-day seizure frequency vs baseline, measured over approximately a 3-month period, that met specific response thresholds: ≥50%, ≥75%, ≥90%, and 100% among those who completed the 12-week titration phase. Sustainability of response was measured using a Kaplan-Meier (KM) method for time to loss of response, defined as the first occurrence of 2 consecutive visits below the given response level after the index event.

Results Two hundred fourteen patients with similar characteristics to the primary C021 study were eligible for evaluation. Of those, 188, 177, 160, and 145 patients who achieved a ≥50%, ≥75%, ≥90%, and 100% response, respectively, at any point in the maintenance phase, were analyzed. For each level of response (in ascending order), 84%, 75%, 72%, and 64% of patients sustained their response after 1 year and 73%, 67%, 60%, and 53% of patients sustained their response after 2 years. After the initial loss of response events, the KM curves flattened and showed that patients with ≥50%, ≥75%, ≥90%, and 100% response rates had a ≥50% probability of sustaining the response through the 2.5-year follow-up period. Most patients exited the analysis due to the end of data collection.

Conclusions Continued treatment with cenobamate resulted in a sustained response during the maintenance phase of therapy, which was sustainable through the end of approximately 2.5 years of follow-up.

Authors/Disclosures
David G. Vossler, MD, FAAN (David G. Vossler MD FAAN FAES FACNS) PRESENTER	Dr. Vossler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $0-$499 for serving as a Consultant for Biohaven 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 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 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.
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 $100,000-$499,999 for serving on a Speakers Bureau for SK Life Science.
Sean Stern (SK life science)	Mr. Stern has received personal compensation for serving as an employee of SK Life Science.
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 Raport. 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. 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 a non-compensated relationship as a Board President with Epilepsy Foundation of Idaho that is relevant to AAN interests or activities.