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

This study has been completed.
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
First received: April 22, 2005
Last updated: August 1, 2012
Last verified: August 2012
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 Intervention Phase
Migraine Headaches
Drug: RWJ-333369
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by SK Life Science:

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

Estimated Enrollment: 300
Study Start Date: March 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  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: 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.
  More Information

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 
Study First Received: April 22, 2005
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Life Science:
Migraine headaches
Head pain

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

ClinicalTrials.gov processed this record on May 26, 2016