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Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures (PROSPER1)
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Details
| Lead sponsor | Supernus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 366 |
| Start date | 2008-11 |
| Completion | 2010-11 |
Conditions
- Epilepsies, Partial
Interventions
- Placebo
- 2400mg SPN-804
- 1200mg SPN-804
Primary outcomes
- PCH(T), ITT — Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\[T\]), Intent-to-Treat population.
Countries
United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, Russia