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 : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Brivaracetam (BRV)||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
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.
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 :||December 2023|
|Estimated Study Completion Date :||January 2024|
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.
- Number of subjects with at least one treatment-emergent adverse event reported during the evaluation period [ Time Frame: From Baseline to End of Study (up to 6 years) ]
- Number of subjects with at least one treatment-emergent adverse event leading to discontinuation during the evaluation period [ Time Frame: From Baseline to End of Study (up to 6 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 6 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||+1 877 822 9493 (UCB)|