A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.
- Sponsor
- SK Life Science, Inc.
- Study ID
- NCT00740623
- Phase
- PHASE3
- Status
- Completed
Conditions
- Epilepsy, Complex Partial
- Epilepsy, Partial, Motor
- Epilepsy, Simple Partial
- Focal Motor Epilepsy
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Carisbamate — DRUG800 mg/day for 14 weeks
- placebo — DRUGplacebo for 14 weeks
- Carisbamate — DRUG1,200 mg/day for 14 weeks
Study Details
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy.
Key Dates
- Start date
- Jan 31, 2009
- Status verified
- Jan 2013
- Primary completion
- Oct 31, 2009
- Completion
- Apr 30, 2010
Study Design
- Enrollment
- 547 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 001Carisbamate 800 mg/day for 14 weeks
- Experimental: 002Carisbamate 1,200 mg/day for 14 weeks
- Placebo Comparator: 003placebo for 14 weeks
Primary Outcome Measure
Primary efficacy endpoints are percent reduction in partial onset seizure frequency in the US and the rest of the world (excluding Europe, Australia, New Zealand, S Africa), and responder rate for Europe, Australia, New Zealand, S Africa [ Time Frame: from baseline relative to the entire double-blind treatment phase (14 weeks) ]