Status:
COMPLETED
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Epilepsy
Epilepsies, Partial
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.
Detailed Description
333369EPY2006 is the open-label extension study that follows the double-blind study 333369EPY2003. In an open label study such as 333369EPY2006, both the physician and the patient know the name of the...
Eligibility Criteria
Inclusion
- Patients must complete Visit 8 (Day 112) of the double-blind treatment phase of Study EPY-2003 to be eligible for entry into the open-label treatment phase of Study EPY-2006.
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 patients who are pregnant or nursing.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT00210522
Start Date
May 1 2005
End Date
June 1 2010
Last Update
January 24 2013
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