Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

Phase 2

Completed

• Conditions: Refractory Epilepsy

• Registration Number: NCT00228969
• Lead Sponsor: SK Life Science, Inc.

Brief Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18-70 years old,
2. Diagnosis of epilepsy for at least 1 year,
3. Presenting, on average, at least 3 partial onset seizures per month,
4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),

Exclusion Criteria

1. Have experienced status epilepticus in the past 3 months,
2. Have any serious diseases,
3. History of major psychiatric disorders within the past 2 years.
4. Have received an experimental drug/device within the past 30 days
5. Are pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified