NCT06315322

A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.

Conditions

• Childhood Absence Epilepsy
• Juvenile Absence Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam Film-coated tablet	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: 2024-07-10
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2024-03-18
• Last updated: 2026-04-13

Locations

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

Regulatory

• FDA-regulated drug study