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Abstract Details

Long-term Safety of Adjunctive Cenobamate in Patients with Uncontrolled Focal Seizures: Open-label Extension of a Randomized Clinical Study
Epilepsy/Clinical Neurophysiology (EEG)
S25 - Epilepsy/Clinical Neurophysiology (EEG) 2 (2:00 PM-2:12 PM)
006
To report long-term safety outcomes from the ongoing open-label extension (OLE) of the YKP3089C013 (C013) study.
A 12-week, double-blind (DB), placebo-controlled C013 study which demonstrated significant reductions in median seizure frequency per month with adjunctive cenobamate 200mg/day has been completed. We now report long term retention and dose in open label extension (OLE).
Adults 18-65 years old with uncontrolled focal seizures who had ≥3 seizures/month despite treatment with stable doses of 1-3 antiepileptic drugs were randomized to receive placebo or cenobamate 200mg/day. The study had a 6-week titration phase and a 6-week maintenance phase. Patients who completed the DB study were eligible to enroll in an OLE. At the end of DB treatment, patients were either tapered off study drug before transitioning to open-label treatment or were allowed to directly convert to open-label cenobamate without being tapered off, if medically warranted. The maximum daily dose of cenobamate during the OLE was 400mg.
Of 158 eligible patients, 149 entered the OLE, including 76 patients originally randomized to cenobamate and 73 patients originally randomized to placebo who transitioned to cenobamate. Median duration of cenobamate exposure was 60.6 months. Median modal daily cenobamate dose was 200mg. As of April 2018, 86 patients (57.7%) remained in the OLE. Reasons for discontinuation overall were withdrawal by patient (18.8%), adverse events (9.4%), other (8.7%), and lost to follow-up (2.7%). Dizziness, headache, and somnolence were the most frequently reported TEAEs. Serious TEAEs occurred in 22.8% of patients. Serious TEAEs occurring in >1% of patients were seizure (n=5) and pneumonia, sepsis, and osteoarthritis (n=2 each). TEAEs leading to discontinuation were reported in 9.4% of patients overall.
Adjunctive cenobamate was generally well tolerated with long-term treatment, with 58% of patients ongoing at the time of this analysis. Most TEAEs were central nervous system-related, consistent with the DB study.
Authors/Disclosures
Steve Chung, MD, FAAN (Banner University Medical Center)
PRESENTER 		The institution of Dr. Chung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ucb pharma. Dr. Chung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SK Life sciences. Dr. Chung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eisai. Dr. Chung has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for eisai. Dr. Chung has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for ucb. Dr. Chung has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for SK Life sciences. Dr. Chung has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for sunovion.
Jacqueline French, MD, FAAN (NYU Comprehensive Epilepsy Ctr) Dr. French has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Epilepsy Foundation. The institution of Dr. French has received research support from Epilepsy Study Consortium/ Epilepsy Foundation (Funded by UCB). The institution of Dr. French has received research support from GW/One8 Foundation/FACES. The institution of Dr. French has received research support from NINDS. The institution of Dr. French has received research support from Xenon. The institution of Dr. French has received research support from Cerevel. The institution of Dr. French has received research support from FACES. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Epilepsy Study Consortium. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Praxis. Dr. French has received personal compensation in the range of $100,000-$499,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Angelini that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Alterity Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Bright minds Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerecin Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Arvelle that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Beacon biosignals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biohaven Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bloom Science Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant, scientific advisory board with Camp4 Therapeutics Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Scientific Advisory Board with Cerebral Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Coda Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Genentech Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Crossject that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eisai, that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Eliem Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Encoded Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with iQure Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Engrail that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epihunter that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a SAB with Epiminder that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epitel Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Equilibre BioPharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Grin Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with GW Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Janssen Pharmaceutica that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Jazz Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Knopp Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Lipocine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with LivaNova that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Longboard Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Lundbeck that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Marinus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Modulight Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant,SAB with Neumirna Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant,SAB with Neurocrine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuroelectrics USA Corporation that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuronetics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ono Pharmaceutical Co that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Otsuka Pharmaceutical Development that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Ovid Therapeutics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Paladin Labs Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LTY Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with SK Life Sciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Stoke that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Supernus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Takeda that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with UCB Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ventus Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, steering committee with Xenon that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Korro Bio Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with NeuroPro Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Receptor that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory board with Sage Therpeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Third Rock Ventures that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Vida Ventures Management that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Pfizer that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Agrithera, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting with Autifony therapeutics, Unlimited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Baergic Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Biogen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Biomarin Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Axonis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Capsida Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Access Industries that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Acuta Capital Partners that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Afaci that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Ceribell that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Clinical 好色先生 Alliance that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EcoR1 Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cowen and Company LLC that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epalex that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Iqvia RDS that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal Therapeutics Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurona Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuroventis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurvati that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurelis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Harmony/Epigenyx that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neuropace that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Noema that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rafa Laboratories that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rivervest Venture Partners that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Taysha Gene Therapies that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Uniqure that is relevant to AAN interests or activities.
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.
Sang Kun Lee, MD (Seoul national University Hospital) Prof. Lee has nothing to disclose.
Maciej Maciejowski, MD (Neurology Dept Silesian Medical University) No disclosure on file
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.
Michael R. Sperling, MD, FAAN (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.