NCT04666610

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Conditions

• Childhood Absence Epilepsy
• Juvenile Absence Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	* Pharmaceutical form: Oral solution * Route of administration: Oral use Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
OTHER	Placebo	Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Timeline

• Start date: 2021-07-29
• Primary completion: 2026-08-24
• Completion: 2026-08-24
• First posted: 2020-12-14
• Last updated: 2026-03-13

Locations

35 sites across 7 countries: United States, Georgia, Italy, Romania, Slovakia, Spain, Ukraine

Regulatory

• FDA-regulated drug study