Status:
COMPLETED
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.
Eligibility Criteria
Inclusion
- Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
- Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
- Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 (V1)
- Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
- Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a concomitant AED
Exclusion
- History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
- History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00464269
Start Date
September 1 2007
End Date
January 1 2009
Last Update
July 21 2022
Active Locations (69)
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States