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A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
Details
| Lead sponsor | UCB Pharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 228 |
| Start date | 2007-08 |
| Completion | 2009-09 |
Conditions
- Epilepsy
Interventions
- Keppra XR
- Keppra XR
Primary outcomes
- The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase — 112 days
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.
Countries
United States, Mexico, Poland, Russia