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Abstract Details

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures, With Optional Open-Label Extension
Epilepsy/Clinical Neurophysiology (EEG)
P8 - Poster Session 8 (8:00 AM-9:00 AM)
9-011

This randomized, controlled, double-blind, multinational study (NCT04557085) evaluated efficacy and safety of adjunctive cenobamate in Asian patients with uncontrolled focal seizures.

Cenobamate, an antiseizure medication (ASM) approved in the US, Europe, and other countries for the treatment of focal seizures in adults, has shown good efficacy in focal seizures.

Adults 18-70 years old with ≥8 focal seizures during an 8-week baseline period, despite treatment with 1-3 ASMs, were randomized 1:1:1:1 to placebo or adjunctive cenobamate 100, 200, or 400 mg once daily. The study included an 18-week titration phase and 6-week maintenance phase and used the currently approved cenobamate titration schedule. The primary outcome was median percent change from baseline in 28-day seizure frequency for all focal aware motor, focal impaired aware, or focal to bilateral tonic-clonic seizures in the modified intent-to-treat maintenance phase population (MITT-M, ≥1 dose of study drug and ≥1 maintenance phase efficacy measure).
Among 519 patients randomized (mean age 35.7 years), 446 were included in the MITT-M population (placebo, n=117; 100 mg, n=113; 200 mg, n=113; and 400 mg, n=103). Median percent changes in 28-day seizure frequency from baseline were -25.9% for placebo vs -42.6%, -78.3%, and
-100% for cenobamate 100, 200, and 400 mg, respectively (P<0.001 each). 100% responder rates during the 12-week treatment period, combining the last 6 weeks of titration and the 6-week maintenance phase, were 0.8% (1/122) for placebo vs 8.5% (10/118) for the 100-mg (P=0.005), 19.7% (23/117) for 200-mg (P<0.001), and 30.6% (37/121) for 400-mg (P<0.001) groups. The most common treatment-emergent adverse events (≥20%) were dizziness and somnolence in cenobamate-treated patients.

This study supports the efficacy and safety profile of cenobamate using the approved titration regimen in a multinational Asian population. Adjunctive cenobamate 100, 200, and 400 mg significantly reduced focal seizure frequency vs placebo and was generally well tolerated.

Authors/Disclosures
Sunita N. Misra, MD (SK Life Science)
PRESENTER 		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.
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.
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.
Sang Kun Lee, MD (Seoul national University Hospital) Prof. Lee 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.
Peimin Yu Dr. Yu has nothing to disclose.