A Study to Test the Safety and Tolerability of Brivaracetam in Pediatric Study Participants With Seizures
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Epilepsy
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 125 years
- Gender
- Both males and females
Description
EP0156 is designed to assess the long-term safety and tolerability of brivaracetam (BRV) from pediatric study participants with epilepsy who participated in the study in neonates, N01349 [NCT03325439], and/or the ongoing, open-label, long-term, follow-up study in pediatric study participants, N01266...
EP0156 is designed to assess the long-term safety and tolerability of brivaracetam (BRV) from pediatric study participants with epilepsy who participated in the study in neonates, N01349 [NCT03325439], and/or the ongoing, open-label, long-term, follow-up study in pediatric study participants, N01266 [NCT01364597], who have the opportunity to continue BRV treatment by participating in EP0156. EP0156 is also designed to assess the long-term safety and tolerability of BRV from directly enrolled (DE) Japanese pediatric study participants with partial-onset seizures (POS) recruited in Japan. In the DE study participants only, pharmacokinetic (PK) data will be evaluated in addition to the safety and tolerability of BRV.
Tracking Information
- NCT #
- NCT04715646
- Collaborators
- Not Provided
- Investigators
- Study Director: UCB Cares 001 844 599 2273 (UCB)
Get Well Soon