Status:

COMPLETED

Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

Lead Sponsor:

SK Life Science, Inc.

Conditions:

Refractory Epilepsy

Eligibility:

All Genders

18-79 years

Phase:

PHASE2

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 betw...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

February 1 2005

Trial Type :

INTERVENTIONAL

End Date :

May 1 2006

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00228969

Start Date

February 1 2005

End Date

May 1 2006

Last Update

August 2 2012

Active Locations (61)

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Page 1 of 16 (61 locations)

1

Birmingham, Alabama, United States

2

Huntsville, Alabama, United States

3

Mobile, Alabama, United States

4

Northport, Alabama, United States

Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy | DecenTrialz