Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.

Criteria

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.