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Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00228969
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Drug: RWJ-333369 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : February 2005
Primary Completion Date : May 2006
Study Completion Date : May 2006


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228969


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

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT00228969     History of Changes
Other Study ID Numbers: 333369-EPY-2003
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

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