A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of adjunctive cenobamate in Asian patients with focal seizures.

ABSTRACT:

Objectives

This randomized, double-blind, placebo-controlled study (NCT04557085), conducted in China, Japan, and the Republic of Korea, evaluated the efficacy and safety of adjunctive cenobamate in patients with uncontrolled focal seizures.

Methods

Adults 18-70 years of age with ≥8 seizures (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic) during an 8-week baseline, despite treatment with 1-3 antiseizure medications (ASMs), were randomized 1:1:1:1 to placebo or cenobamate 100, 200, or 400 mg/day. The study included an 18-week titration phase and a 6-week maintenance phase. The primary efficacy analysis was a hierarchical step-down comparison of the percent change from baseline in 28-day seizure frequency vs placebo during the maintenance phase

SUBMITTER: Lee SK 

PROVIDER: S-EPMC12927683 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature