Clinical Trial: A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset

Brief Summary: 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.

Detailed Summary: According to the World Health Organization (WHO), epilepsy afflicts more than 50 million people worldwide. Older antiepileptic drugs are still commonly used, despite a diverse range of side effects. New AEDs approved since the early 1990s have shown an improved tolerability profile. Nonetheless, approximately 30% of patients, particularly those with partial onset seizures, are not well controlled even on the newer treatments or they experience significant side effects secondary to treatment. Therefore, the development of new drugs with effectiveness or safety and tolerability advantages over currently marketed antiepileptic drugs is needed. This is a randomized (study medication assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned study medication), placebo-controlled, parallel-group, multicenter study. The study has 3 phases: an 8-week pretreatment phase including screening and a baseline period, a 14-week double blind treatment phase, including a 2-week titration period and a 12-week maintenance period, and a 4 week posttreatment phase. During the 56-day baseline period, patients will be required to have at least 6 partial onset seizures, no more than >= 100 partial onset seizures per 28 days, and no seizure-free period for more than 3 weeks to be eligible to enter the double-blind treatment phase of the study. During the double-blind treatment phase of study CARISEPY3013, patients will be randomly assigned to receive 800 mg/day carisbamate, 1,200 mg/day carisbamate, or placebo for 14 weeks. The total duration of study CARISEPY3013 is approximately 26 weeks for each subject. Patients who complete the double-blind treatment phase will be eligible to enter the separate extension study CARISEPY3014. Safety assessments include 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 n
Sponsor: SK Life Science

Current Primary Outcome: 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) ]

Original Primary Outcome: 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

Current Secondary Outcome: Secondary endpoints are percent reduction in partial onset seizure frequency for EuropeAustraliaNew Zealand S Africa, percent reduction in secondarily generalized seizure and time to onset of treatment effect on partial onset seizure frequency reduction [ Time Frame: from baseline relative to the entire double-blind treatment phase (14 weeks) ]

Original Secondary Outcome:

Information By: SK Life Science

Dates:
Date Received: August 21, 2008
Date Started: January 2009
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013