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Abstract Details

Predictors of Sustainability of Response With Cenobamate: Post-hoc Subset Analysis of a Phase 3, Open-Label, Study
Epilepsy/Clinical Neurophysiology (EEG)
P14 - Poster Session 14 (11:45 AM-12:45 PM)
9-005
Cenobamate is an antiseizure medication (ASM) approved in the US and EU for the treatment of focal seizures.
We evaluated seizure reduction achieved with adjunctive cenobamate and clinical characteristics associated with maintaining response in a post-hoc analysis from a phase 3, open-label, safety study.
Patients 18-70 years old with uncontrolled focal seizures taking stable doses of 1-3 ASMs were enrolled. We assessed 100% seizure reduction from baseline achieved over any 3-month interval in the maintenance phase. Loss of response was defined as a visit with seizure reduction <100% vs baseline. Time to 1st and 4th loss of response was the time between onset of response and the patient’s 1st or 4th occurrence of a loss of response, respectively. Logistic regression models were used to evaluate associations with clinical response. Characteristics assessed included sex, race, age, baseline seizure frequency (<3 vs ≥3 seizures/28 days), number of ASMs, use of branded ASMs, presence of secondary generalized tonic-clonic seizures, prior epilepsy-related surgery, and baseline concomitant drug load using defined daily dose (ratios of a patient’s prescribed concomitant ASM doses divided by a standardized daily maintenance dose were summed).
Of the 214 patients who received ≥1 dose of cenobamate during the maintenance phase (mean age, 41.9 years; median maintenance treatment duration, 29.5 months), 145 (67.8%) had 100% seizure reduction over any 3-month interval. Among patients who initially achieved 100% seizure reduction, the median time to breakthrough seizures was 7 months. Patients with lower baseline concomitant drug load and lower baseline seizure frequency (4th loss only) were more likely to maintain 100% seizure reduction. No other characteristics examined reached significance within the models for 100% seizure reduction.
In this post-hoc analysis, adjunctive cenobamate led to sustained seizure freedom in patients, including those with characteristics associated with treatment-refractory epilepsy. See also abstract by Wechsler et al.
Authors/Disclosures
Sean Stern (SK life science)
PRESENTER
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.
Wesley Kerr, MD, PhD (University of Pittsburgh) Dr. Kerr has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Lifesciences. Dr. Kerr has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven Pharmaceuticals. Dr. Kerr has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EpiTel. Dr. Kerr has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Kerr has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven Pharmaceuticals. Dr. Kerr has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerebral Therapeutics. Dr. Kerr has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Epilepsia. The institution of Dr. Kerr has received research support from NINDS. The institution of Dr. Kerr has received research support from American Epilepsy Society. The institution of Dr. Kerr has received research support from American Academy of Neurology. Dr. Kerr has received publishing royalties from a publication relating to health care.
Clarence Wade (SK life science) Mr. Wade has received personal compensation for serving as an employee of SK Life Science, Inc..
David G. Vossler, MD, FAAN (David G. Vossler MD FAAN FAES FACNS) 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 $5,000-$9,999 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.