Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

Refractory Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228969
• Other study ID #: 333369-EPY-2003
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: August 1, 2012
• Start date: February 2005
• Est. completion date: May 2006

Study information

• Verified date: August 2012
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Refractory Epilepsy

Intervention

Drug:
• RWJ-333369

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Countries where clinical trial is conducted

United States,  Argentina,  Hungary,  Netherlands,  Poland,  Russian Federation,  Spain,  United Kingdom,