An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
- Sponsor
- SK Life Science, Inc.
- Study ID
- NCT00744731
- 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
- placebo — DRUGplacebo for 1 week
- carisbamate — DRUG400 mg/day to 1,200 mg per day
Study Details
The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.
Key Dates
- Start date
- Jan 31, 2009
- Status verified
- Jun 2013
- Primary completion
- Aug 31, 2010
- Completion
- Aug 31, 2010
Study Design
- Enrollment
- 403 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 001placebo placebo for 1 week
- Experimental: 002carisbamate 400 mg/day to 1,200 mg per day
Primary Outcome Measure
Safety will be evaluated by the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations [ Time Frame: after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary ]