NCT01364597

Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 28 Days – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

Detailed description

This is a Phase 3, open-label, single-arm, multicenter, long-term study to evaluate the safety and efficacy of brivaracetam (BRV) in children with epilepsy. This study was initially designed for pediatric subjects who had completed a previous BRV study. With protocol amendment 4, enrollment for "directly enrolled" subjects was modified from 'up to' an additional 100 subjects to "at least" 100 subjects, keeping the planned total enrollment of approximately 600 subjects to allow flexibility in the number of patients reaching 1 year of exposure. With protocol amendment 5, entry criteria for subjects coming for other pediatric core studies in development were included. Additional clarity was provided for subjects enrolled in N01266 that temporary roll over to one of those studies and resume participation in N01266. With protocol amendment 6, central EEG reading and entry visit EEG were removed. Some clarifications on study assessments (questionnaires, EEGs) was provided and inclusion criteria were aligned from an earlier local amendment. With protocol amendment 7, the pregnancy section was updated to clarify that Pregnancy Report and Outcome Form has to be completed in all pregnancies. With protocol amendment 8, re-categorization of study variables in compliance with reporting registries was performed. Modifications due to COVID19 pandemic were implemented and clarification provided that participants may transition to another BRV study. The primary objective is to evaluate the long-term safety and tolerability of BRV. The secondary objective is to assess the efficacy of BRV during long-term exposure.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam (BRV)	The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight \>40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights \>50kg) is reached.

Timeline

• Start date: 2011-08-01
• Primary completion: 2022-02-03
• Completion: 2022-02-03
• First posted: 2011-06-02
• Last updated: 2025-10-20
• Results posted: 2022-08-29

Locations

56 sites across 12 countries: United States, Belgium, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study