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Abstract Details

Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population
Epilepsy/Clinical Neurophysiology (EEG)
P8 - Poster Session 8 (8:00 AM-9:00 AM)
9-010

To report changes in seizure frequency during 2-week intervals of the early titration phase of a multicenter, randomized, double-blind, placebo-controlled, dose-response study (NCT04557085) of adjunctive cenobamate for the treatment of focal seizures in a multinational Asian population.

Cenobamate is an antiseizure medication (ASM) approved in the US, Canada, and Europe for the treatment of focal seizures in adults. Cenobamate demonstrated efficacy in treating focal seizures in previous controlled studies in adults.
Patients 18-70 years with uncontrolled focal seizures despite treatment with 1-3 ASMs were randomized 1:1:1:1 to receive either placebo or adjunctive cenobamate 100, 200, or 400 mg once daily, initiated at 12.5 mg/day and up-titrated at 2-week intervals. Changes in seizure frequency at 2-week intervals during early titration (first 8 weeks) were assessed for cenobamate (combined dose groups) vs placebo in the modified intent-to-treat maintenance population (MITT-M, ≥1 dose and any post-baseline seizure data in the maintenance phase). Safety and tolerability were also assessed.
519 patients were randomized (mean age 35.7 years); 446 were included in the MITT-M population (placebo, n=117; cenobamate, n=329). During Weeks 1-2, 3-4, 5-6, and 7-8 of titration, cenobamate-treated patients experienced a median reduction from baseline in 28-day seizure frequency of 16.0% (vs 20.0% placebo, P=0.81), 27.2% (vs 22.2% placebo, P=0.42), 42.9% (vs 15.4% placebo, P=0.002), and 55.6% (vs 20.0% placebo, P<0.001) respectively. During Weeks 1-2, 3-4, 5-6, and 7-8, the ≥50% responder rates in the MITT-M population were 26.1% for cenobamate (vs 32.5% placebo, P=0.19), 36.5% (vs 25.6% placebo, P=0.03), 45.3% (vs 34.2% placebo, P=0.04), and 54.4% (vs 29.1% placebo, P<0.001), respectively. The most common TEAEs (≥20%) were dizziness and somnolence in the cenobamate dose groups.
Statistically significant reductions in focal seizure frequency were observed early during cenobamate titration (at Week 5-6). Adjunctive cenobamate was generally well-tolerated.
Authors/Disclosures
Pranoti Pradhan
PRESENTER 		Dr. Pradhan has received personal compensation for serving as an employee of SK Life Science. Dr. Pradhan has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Pradhan has stock in Neurocrine Biosciences.
Louis Ferrari (SK Lifescience) Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
Zhen Hong Prof. Hong has nothing to disclose.
Sang Kun Lee, MD (Seoul national University Hospital) Prof. Lee has nothing to disclose.
Sunita N. Misra, MD (SK Life Science) Dr. Misra has received personal compensation for serving as an employee of SK Life Science, Inc. An immediate family member of Dr. Misra has received personal compensation for serving as an employee of Neurocrine Biosciences.
Peimin Yu Dr. Yu has nothing to disclose.
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.
Kensuke Kawai, MD, PhD Prof. Kawai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SK Biopharma. Prof. Kawai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Japan. Prof. Kawai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zimmer Biomet. Prof. Kawai has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EP Medical. Prof. Kawai has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Prof. Kawai has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Daiichi-Sankyo.