An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.

Criteria

Inclusion Criteria:

• Must have completed the 14-week double-blind treatment phase of study CARISEPY3013

• must be willing/able to follow the restrictions and prohibitions of the protocol

• must be able to complete the patient diaries correctly (patients or legally acceptable representatives)

• must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives)

• adolescents capable of understanding the nature of the study must provide assent to participate in the study

Exclusion Criteria:

• Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.