Efficacy, safety, and tolerability of adjunctive brivaracetam in adult Asian patients with uncontrolled focal‐onset seizures: A phase III randomized, double‐blind, placebo‐controlled trial

Objective Evaluate efficacy, safety, and tolerability of adjunctive brivaracetam (BRV) in adult Asian patients with focal‐onset seizures (FOS). Methods Phase III, randomized, double‐blind, placebo‐controlled study (EP0083; NCT03083665) evaluating BRV 50 mg/day and 200 mg/day in patients (≥16–80 years) with FOS with/without secondary generalization (focal to bilateral tonic–clonic seizures) despite current treatment with 1 or 2 concomitant antiseizure medications. Following an 8‐week baseline, patients were randomized 1:1:1 to placebo, BRV 50 mg/day, or BRV 200 mg/day, and entered a 12‐week treatment period. Efficacy outcomes: percent reduction over placebo in 28‐day FOS frequency (primary); 50% responder rate in FOS frequency; median percent reduction in FOS frequency from baseline; seizure freedom during treatment period (secondary). Primary safety endpoints: incidences of treatment‐emergent adverse events (TEAEs); TEAEs leading to discontinuation; serious TEAEs. Results In this study, 448/449 randomized patients (mean age, 34.5 years; 53.8% female) received ≥1 dose of study medication (placebo/BRV 50 mg/BRV 200 mg/day: n = 149/151/148). Percent reduction over placebo in 28‐day adjusted FOS frequency was 24.5% (p = 0.0005) and 33.4% (p