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A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine

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: NCT00109083
Recruitment Status : Completed
First Posted : April 25, 2005
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
SK Life Science

Brief Summary:
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.

Condition or disease Intervention/treatment Phase
Migraine Headaches Drug: RWJ-333369 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine
Study Start Date : March 2002
Primary Completion Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Primary Outcome Measures :
  1. Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Established history of migraines for at least 1 year;
  • Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
  • Migraines must have first started before age 50.

Exclusion Criteria:

  • Most frequent headache type is not migraine;
  • Failed 3 or more studies of effective migraine-preventing medications;
  • Overuse of pain medications to treat migraines;
  • Not willing to stop use of migraine-preventing medications;
  • Significant serious concomitant diseases.

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): NCT00109083

  Show 25 Study Locations
Sponsors and Collaborators
SK Life Science
Study Director: Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT00109083     History of Changes
Other Study ID Numbers: 333369-MIG-2001
First Posted: April 25, 2005    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by SK Life Science:
Migraine headaches
Head pain

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms