Abstract Details

Title Efficacy of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures Based on Number of Concomitant Antiepileptic Drugs, Seizure Frequency, and Epilepsy Duration at Baseline

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-010

Objective To conduct a post-hoc assessment of the effects of baseline features, including number of concomitant antiepileptic drugs (AEDs), seizure frequency, and epilepsy duration, on the reduction in focal seizure frequency during the maintenance phase of a double-blind, placebo-controlled, dose response study (YKP3089C017 [C017]).

Background C017 showed that cenobamate 100, 200, and 400mg were effective for the treatment of focal seizures.

Design/Methods Adults 18-70 years old with uncontrolled focal seizures and who had ≥8 focal seizures during the 8-week baseline period, despite treatment with stable doses of 1-3 AEDs, were randomized to placebo or cenobamate 100, 200, or 400mg/day. The study included a 6-week titration phase and 12-week maintenance phase.

Results In 64 patients who were taking 1 baseline AED, median percent seizure frequency reductions/28 days were 24.1% for placebo and 44.7%, 57.6%, and 86.0% for cenobamate (100, 200, 400mg/day, respectively). In 156 patients who were taking 2 AEDs, median percent reductions were 33.3% for placebo and 41.4%, 57.9%, and 57.0% for cenobamate (100, 200, 400mg/day). In 177 patients who were taking 3 AEDs, median percent reductions were 26.4% for placebo and 41.5%, 49.3%, and 67.4% for cenobamate (100, 200, 400mg/day). When assessed by median baseline seizure frequency/28 days (9.5), the greatest reduction in median percent seizure frequency for patients with baseline seizure frequency ≤9.5 occurred in the 200mg cenobamate group (66.5%); the greatest reduction for patients with baseline seizure frequency >9.5 occurred in the 400mg cenobamate group (70.7%). Similar trends were observed when assessed by median duration of epilepsy at baseline (≤23 years/>23 years). Responder rates (≥50% seizure reduction) were numerically higher in each cenobamate group than placebo, regardless of baseline seizure frequency or disease duration.

Conclusions Clinically relevant reductions in seizure frequency occurred with adjunctive cenobamate regardless of baseline number of AEDs, seizure frequency, or disease duration.

Authors/Disclosures
William E. Rosenfeld, MD, F�鶹��ýӳ�� (Comprehensive Epilepsy Care Center for Children and Adults) PRESENTER	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.
Arkady Nisman, PharmD (SK Life Science, Inc.)	Dr. Nisman has received personal compensation for serving as an employee of SK Life Science, Inc.. Dr. Nisman has a non-compensated relationship as a Senior Director, Medical Affairs with SK Life Science, Inc. that is relevant to �鶹��ýӳ�� interests or activities.
	No disclosure on file
Louis Ferrari (SK Lifescience)	Louis Ferrari has received personal compensation for serving as an employee of SK Life science.

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