Status:
COMPLETED
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Epilepsy, Partial, Motor
Epilepsy, Complex Partial
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 cou...
Detailed Description
CARISEPY3014 is the open-label extension study that follows the double-blind study CARISEPY3013 (NCT00740623). In an open label study such as CARISEPY3014, both the physician and the patient know the ...
Eligibility Criteria
Inclusion
- 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
- Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00744731
Start Date
January 1 2009
End Date
August 1 2010
Last Update
June 18 2013
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