Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™)
|ClinicalTrials.gov Identifier: NCT01339559|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2011
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Brivaracetam||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||767 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy|
|Actual Study Start Date :||May 11, 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Brivaracetam with a maximum of 200 mg/day
Tablet, Flexible dosing up to 200 mg/day, twice daily.
The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
Other Name: UCB34714
- Occurrence of at least one Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ]
- Withdrawal due to Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ]
- Occurrence of a Serious Advere Event [ Time Frame: From entry Visit 1 through End of Treatment (up to approximately 4 years) ]
- Partial onset seizure (type I) frequency per 28 days during the Evaluation Period [ Time Frame: Evaluation Period (approximately 4 years) ]28 day adjusted seizure frequency will be calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
- Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period [ Time Frame: Baseline from originating study; Evaluation Period (approximately 4 years) ]Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). Negative changes from Baseline indicate an improvement (ie, a reduction).
- Responder rate in POS (type I) frequency over the Evaluation Period [ Time Frame: Baseline Period: Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). ]A responder is defined as a subject with a ≥50 % reduction in seizure frequency from the Baseline Period of the previous study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339559
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|Study Director:||UCB Cares||+1 844 599 2273 (UCB)|