Status:
COMPLETED
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Epilepsy
Epilepsy, Focal
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.
Detailed Description
According to the World Health Organization (WHO), epilepsy afflicts more than 50 million people worldwide. Despite the ongoing use of older antiepileptic drugs (AEDs) and the development of newer trea...
Eligibility Criteria
Inclusion
- Male or Female, 16 year or older
- Clinical diagnosis of focal epilepsy for at least 1 year
- History of poor response to at least 1 anti-epileptic drug in the past
- Current treatment with 1 or 2 anti-epileptic drugs
- Should have at least 3 seizures per month
Exclusion
- Generalized epilepsy
- Cannot count your seizures
- 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 :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00425282
Start Date
November 1 2006
End Date
October 1 2007
Last Update
June 20 2012
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