Abstract Details

Title Long-Term Efficacy of Cenobamate by Concomitant Antiseizure Medication: Post-hoc Analysis of the C017 Open-label Extension Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 024

Objective To report long-term outcomes with adjunctive cenobamate by concomitant antiseizure medication (ASM) from the open-label extension (OLE) of the YKP3089C017 (C017) study.

Background Patients with uncontrolled focal epilepsy despite 1-3 ASMs achieved significantly greater reductions in median seizure frequency/month with adjunctive cenobamate (100, 200, or 400 mg/day) over placebo. Patients completing the double-blind period could continue in the OLE.

Design/Methods Patients entering the OLE underwent a 2-week blinded conversion to a target dose of cenobamate 300 mg/day (max dose 400 mg/day). Median percent reduction in seizure frequency/28 days from baseline (double-blind study) was compared among patients taking regimens including concomitant levetiracetam, lamotrigine, or lacosamide at baseline.

Results 354/437 randomized patients (81%) entered the OLE and had any OLE seizure data; 60.2% (213/354) remained on therapy through 4 years. Most patients (82.8% [293/354]) were taking 2-3 concomitant ASMs at baseline of the double-blind study; 156 (44.1%) were on levetiracetam, 119 (33.6%) on lamotrigine, and 61 (17.2%) on lacosamide. Median percent reduction from baseline during the first 6 months of treatment in the OLE was 65.4% for all patients and 65.4%, 59.0%, and 61.0% for levetiracetam, lamotrigine, and lacosamide-treated patients. Reduction in seizure frequency increased over the OLE, up to a median 76.1% at 42-48 months for all patients (n=213) and 75.5%, 72.0%, and 72.5% for patients taking levetiracetam (n=100), lamotrigine (n=66), and lacosamide (n=38), respectively. 100% responder rate (zero seizures) at Months 42-48 was 23.0% for all cenobamate patients and 20.0%, 19.7%, and 13.2% for levetiracetam, lamotrigine, and lacosamide-treated patients, respectively. Most common adverse events among levetiracetam, lamotrigine, and lacosamide-treated patients included dizziness (19.0%, 19.4%, 18.8%), somnolence (9.6%, 12.0%, 14.4%), fatigue (5.7%, 6.6%, 11.4%), and diplopia (6.8%, 11.1%, 10.9%).

Conclusions Adjunctive treatment with cenobamate was associated with sustained long-term efficacy in patients taking regimens including levetiracetam, lamotrigine, or lacosamide at the beginning of the OLE.

Authors/Disclosures
Louis Ferrari (SK Lifescience) PRESENTER	Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
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 $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science.

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