A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

Phase 3 Completed 449 enrolled UCB Biopharma SRL

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects \>= 16 years to 80 years of age.

Timeline

Start: 2017-08-22
Primary completion: 2022-06-30
Completion: 2022-06-30

Outcome

Met primary endpoint

registry Placebo vs BRV 50 mg/Day; p = 0.0005; Percent reduction over Placebo 24.5 (95% CI 11.7 to 35.5) NCT03083665 ↗

registry Placebo vs BRV 200 mg/Day; p <0.0001; Percent reduction over Placebo 33.4 (95% CI 21.9 to 43.1) NCT03083665 ↗

Publications

Results Usui N, Zhou D, Qin B, Tiamkao S, Cabral-Lim L, Lim KS, Lim SH, Tsai JJ, Watanabe J, Sun W, Dickson N, Moseley B, Bourikas D, Inoue Y. 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. Adv Ther. 2025 Nov;42(11):5639-5652. doi: 10.1007/s12325-025-03357-7. Epub 2025 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brivaracetam	Small molecule	50 mg	Oral
Subject	Brivaracetam	Small molecule	200 mg	Oral