Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT00228969
First received: June 30, 2005
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Refractory Epilepsy
Drug: RWJ-333369
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Study Start Date: February 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228969

  Show 61 Study Locations
Sponsors and Collaborators
SK Life Science
  More Information

No publications provided

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT00228969     History of Changes
Other Study ID Numbers: 333369-EPY-2003
Study First Received: June 30, 2005
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014