NCT04715646

A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Detailed description

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral

Timeline

• Start date: 2021-03-11
• Primary completion: 2030-07-08
• Completion: 2030-07-08
• First posted: 2021-01-20
• Last updated: 2025-06-27

Locations

36 sites across 11 countries: United States, Belgium, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Spain

Regulatory

• FDA-regulated drug study