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An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
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.
Details
| Lead sponsor | UCB Pharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 400 |
| Start date | 2007-09 |
| Completion | 2009-01 |
Conditions
- Epilepsy
Interventions
- Placebo
- Brivaracetam 2.5 mg
- Brivaracetam 10 mg
- Brivaracetam 25 mg
Primary outcomes
- Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period — Baseline to 12-week Treatment Period
Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
Countries
United States, Australia, Brazil, Canada, Mexico