Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
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|ClinicalTrials.gov Identifier: NCT01364597|
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2011
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Brivaracetam (BRV)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 2011|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
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).
- 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) ]
- 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) ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364597
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|Study Director:||UCB Cares||+1 844 599 2273(UCB)|