NCT05109234

A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 2 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Conditions

• Childhood Absence Epilepsy
• Juvenile Absence Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam Film-coated tablet	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
DRUG	Brivaracetam oral solution	* Pharmaceutical form: Oral solution * Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.

Timeline

• Start date: 2022-03-30
• Primary completion: 2025-03-18
• Completion: 2025-03-18
• First posted: 2021-11-05
• Last updated: 2025-10-22
• Results posted: 2025-10-07

Locations

24 sites across 6 countries: United States, Georgia, Italy, Romania, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study