Status:
COMPLETED
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Epilepsy
Epilepsies, Partial
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 c...
Detailed Description
333369EPY2002 is the open-label extension study that follows the double-blind study 333369EPY2001. In an open label study such as 333369EPY2002, both the physician and the patient know the name of the...
Eligibility Criteria
Inclusion
- In order to enter the open label extension, the patient must have completed Study 333369EPY-2001.
Exclusion
- Patients who have seizures that cannot be quantitated accurately
- patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
- patients with a history of drug or alcohol abuse within the past 2 years
- patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
- and female patients who are pregnant or nursing.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00210652
Start Date
July 1 2004
End Date
March 1 2010
Last Update
January 24 2013
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