好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

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 $50,000-$99,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Acadia Pharmaceuticals Inc 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 LLC that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with AFASCI Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Agrithera, Inc. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Alkermes 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, Advisory Board with Angelini Pharma S.p.A. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Autifony Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Axonis Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bain Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Beacon Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biogen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biohaven Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Bloom Science, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bright Minds Biosciences, Inc. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Capsidia Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Cerebral Therapeutics 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, SAB with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, SAB with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Ceribell that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cowen 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 Advisory Board with EcoR1 Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EG 427 that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant, Advisory Board with Eisai 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/Advisory Board with Engrail 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 EpiMinder 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 Harmony that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Ionis Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with iQure Pharma, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with IQVIA that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Janssen Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Jazz Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal Therapeutics 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, SAB with London Research & Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Longboard Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Maplight Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Marinus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Medscape/Web MD 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 with Montara Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Mosaica Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Neumarker that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Neumirna Therapeutics 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 consulting, Advisory Board with Neurocrine 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 NeuroPro Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Neuroventis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Neurona Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, Advisory Board with Neuvarti that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Noema that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Ono Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, Advisory Board with Otsuka that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, Advisory Board with Ovid Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LYT Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with QurAlis Corp that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Receptor Holdings, Inc 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, Advisory Board with Sage Therapeutics, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with SK Life Science that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Stoke that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Stream Neuroscience 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 with Taysha Gene Therapies that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with UCB, Inc 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. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Ventus Therapeutics 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 Consultant, Advisory Board with Xenon Pharmaceuticals 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.