Open-label Long-term Study of Adjunctive 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: From Baseline to End of Study (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: From Baseline to End of Study (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 (up to 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 0.5 mg/kg of brivaracetam twice daily (bid). The maximum allowable brivaracetam dose is 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day for subjects with body weight >40 kg. Subjects <7 years of age will receive oral solution.
Subjects ≥7 years of age will receive tablets and should transition from the oral solution to the equivalent oral tablet dose. The maximum BRV tablet dose allowed in this study will be 200 mg/day (100 mg bid).
Subjects will continue to receive brivaracetam in this study 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 the study, brivaracetam 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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364597
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|