Status:
COMPLETED
An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Epilepsy
Complex Partial Seizures
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.
Detailed Description
333369EPY3004 is the open-label extension study that follows the double-blind studies 333369EPY3001 and 333369EPY3002 (NCT00425282 and NCT00433667, respectively). In an open label study such as 333369...
Eligibility Criteria
Inclusion
- In order to enter the open label extension, the patient must have completed either Study 333369EPY3001 or Study 333369EPY3002.
Exclusion
- Generalized epilepsy
- Currently experiencing seizures that cannot be counted accurately
- Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
- Major psychiatric illness
- Recent drug or alcohol abuse
- Unable to swallow pills
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
991 Patients enrolled
Trial Details
Trial ID
NCT00991757
Start Date
February 1 2007
End Date
October 1 2010
Last Update
June 18 2013
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