Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial.

ABSTRACT:

Introduction

We assessed the time course of treatment-emergent adverse events (TEAEs) in adult Asian patients (in Thailand, Japan, China, Philippines, Malaysia, Singapore, and Taiwan) with focal-onset seizures (FOS) during adjunctive brivaracetam (BRV) treatment.

Methods

Post hoc analysis of EP0083/NCT03083665, a Phase 3, randomized, double-blind, placebo (PBO)-controlled trial that evaluated BRV 50 and 200 mg/day in adult Asian patients (≥ 16-80 years) with FOS. Following an 8-week prospective baseline, patients were randomized 1:1:1 to PBO, BRV 50 mg, or BRV 200 mg and entered a 12-week treatment period.

Results

Overall, 448 patients (mean age 34.5 years; 53.8% female) received ≥ 1 dose of trial medication (PBO/BRV 50 mg/BRV 200 mg: n = 149/151/148 [Safety Set]). Th

SUBMITTER: Usui N 

PROVIDER: S-EPMC12579673 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature