Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)
25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
Time frame: From Week 1 up to Week 17
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Time frame: Baseline through Re-conversion (approximately 31 weeks)
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Time frame: Baseline through Re-conversion (approximately 31 weeks)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Time frame: Baseline through Re-conversion (approximately 31 weeks)
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Phoenix, Arizona, United States
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Fresno, California, United States
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Pasadena, California, United States
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Denver, Colorado, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Conyers, Georgia, United States
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Macon, Georgia, United States
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Peoria, Illinois, United States
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Lexington, Kentucky, United States
...and 43 more locations