NCT03083665

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

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Seizures With or Without Secondary Generalization
• Epilepsy

Interventions

Type	Name	Description
DRUG	Placebo	* Pharmaceutical form: Film-coated tablets * Route of administration: Oral use
DRUG	Brivaracetam	* Pharmaceutical form: Film-coated tablets * Concentration: 25 mg tablets and 50 mg tablets * Route of administration: Oral use

Timeline

• Start date: 2017-08-22
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2017-03-20
• Last updated: 2025-10-14
• Results posted: 2023-11-09

Locations

94 sites across 7 countries: China, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand