Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy|
- Number of subjects with at least one treatment-emergent adverse event reported during the evaluation period (up to 3 years) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Number of subjects with at least one treatment-emergent adverse event leading to discontinuation during the evaluation period (up to 3 years) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
- Reduction from Baseline to the end of the Evaluation Period for the number of seizure days [ Time Frame: Baseline to Last Yearly Evaluation Visit or Early Discontinuation Visit (Approximately 3 years) ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Subjects entering this study from the previous study must be able to tolerate at least 0.4 mg/kg of brivaracetam twice daily (bid) if ≥8 years of age or at least 0.5 mg/kg bid if <8 years of age.
Drug: Brivaracetam (BRV)
Subjects must be able to tolerate at least .4mg/kg of BRV twice daily if ≥8 years of age or at least .5mg/kg bid if <8 years of age. The maximum BRV dose for subjects ≥8 years of age is 3.2mg/kg/day and 4.0mg/kg/day for subjects <8 years of age.
Younger subjects (<7 years of age) will be administered BRV oral solution. Subjects above 50kg will be dosed as adults, up to a maximum total daily dose not exceeding 200mg/day, and should transition from the oral solution to the equivalent oral tablet dose. The maximum BRV tablet dose allowed in this study will be 200mg/day (100 mg bid), which is the maximum allowed dose for those subjects dosed as adults.
Subjects will receive BRV for at least 3 years, or until approval for BRV has been obtained for pediatric subjects in their age range, or until the investigational product development is stopped by the Sponsor.
For subjects who prematurely discontinue, BRV will be down titrated over a maximum of 4 weeks (Down-Titration Period).
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 3, enrollment was expanded to include up to additional 100 subjects as "directly enrolled subjects" ≥4 years to <17 years of age with partial-onset seizures (POS)who had not previously enrolled in a pediatric 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.
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|