Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial.

ABSTRACT:

Introduction

This trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16 years with focal-onset seizures (FOS).

Methods

Interim analysis of data from EP0085 (NCT03250377), a long-term follow-up trial of adjunctive BRV 50-200 mg/day in Japanese and Chinese patients. Post hoc analyses assessed efficacy for 12- and 24-month completers and BRV retention.

Results

At data cutoff (June 1, 2023), 207 patients had enrolled; of these, 157 (75.8%) were ongoing and 50 (24.2%) had discontinued. Overall, 137 patients were 12-month completers and 63 were 24-month completers. Mean age was 36.7 years and 107 (51.7%) patients were female (100 [48.3%] male). Mean duration of epilepsy was 17.

SUBMITTER: Fujimoto A 

PROVIDER: S-EPMC12394343 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature