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Abstract Details

Efficacy of Cenobamate by Concomitant Antiseizure Medications in Patients With Uncontrolled Focal Seizures: Post-hoc Analysis of a Phase 3, Multicenter, Open-Label Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
013
Report post-hoc efficacy of cenobamate by concomitant antiseizure medication (ASM) from 10 US study sites from a global, phase 3 safety study.
Cenobamate is an ASM approved in the US for adults with focal seizures.
Adults with uncontrolled focal seizures taking stable doses of 1-3 ASMs were administered increasing doses of cenobamate (12.5, 25, 50, 100, 150, 200 mg/day) at 2-week intervals. Further increases to 400 mg/day, using 50-mg/day increments every other week, were allowed.
240 patients were evaluated (median exposure duration 30.2 months); 87.9% were taking 2-3 concomitant ASMs at baseline. During maintenance treatment (n=214), ≥50%, ≥75%, ≥90%, and 100% responder rates were achieved by 75.7% (162/214), 57.5% (123/214), 40.2% (86/214), and 13.6% (29/214) of patients, respectively. Among all 240 patients, the most common concomitant baseline ASMs were lacosamide (40.8%), levetiracetam (37.1%), lamotrigine (27.5%), clobazam (15.8%) and zonisamide (16.3%). Baseline ASM use was compared among the following outcomes: continuing cenobamate at last visit (n=177), discontinued from cenobamate (n=63), and 100% seizure reduction ≥12 months at last visit (n=60). A slightly greater percent of patients with 100% seizure reduction ≥12 months took concomitant levetiracetam (43.3%) or zonisamide (21.7%). Slightly fewer patients who discontinued cenobamate took lacosamide (33.3%) or zonisamide (14.3%). Lamotrigine use remained stable across outcomes (27.1% to 28.6%). Fewer patients with 100% seizure reduction ≥12 months took clobazam (10.0%). Concomitant ASMs were decreased most often for AEs including dizziness, ataxia for lacosamide; dizziness, diplopia, sleepiness for lamotrigine; sleepiness/somnolence, cognitive dysfunction, irritability for levetiracetam; sleepiness/somnolence for clobazam, and sleepiness, fatigue for zonisamide.
Cenobamate was associated with clinically relevant seizure reduction when combined with commonly used ASMs. Baseline ASM use was generally consistent among patients continuing cenobamate, discontinuing cenobamate, and achieving 100% seizure reduction ≥12 months. The AEs associated with the combinations were consistent with the known profiles of these ASMs.
Authors/Disclosures
Pavel Klein, MD, FÂé¶¹´«Ã½Ó³»­ (Mid-atlantic Epilepsy and Sleep Center)
PRESENTER
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.
David G. Vossler, MD, FÂé¶¹´«Ã½Ó³»­ (David G. Vossler MD FÂé¶¹´«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.
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, FÂé¶¹´«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 .
Marc Kamin, MD Dr. Kamin has received personal compensation for serving as an employee of SK LIFE SCIENCE INC.
William E. Rosenfeld, MD, FÂé¶¹´«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.