COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 identifier (NCT number): NCT00109083

Layout table for location information
United States, Alabama
Northport, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Berkeley, California, United States
United States, Colorado
Golden, Colorado, United States
United States, Florida
Miami, Florida, United States
St. Petersburg, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Massachusetts
Brockton, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Minnesota
Chaska, Minnesota, United States
United States, Missouri
Springfield, Missouri, United States
United States, North Carolina
Greensboro, North Carolina, United States
United States, North Dakota
Bismarck, North Dakota, United States
United States, Ohio
Cincinnati, Ohio, United States
Mogadore, Ohio, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
Richardson, Texas, United States
United States, Virginia
Alexandria, Virginia, United States
United States, Washington
Olympia, Washington, United States
United States, Wisconsin
Middleton, Wisconsin, United States
Sponsors and Collaborators
SK Life Science, Inc.
Layout table for investigator information
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 Identifier (NCT Number):
Layout table for additonal information
Responsible Party: SK Life Science, Inc. Identifier: NCT00109083    
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, Inc.:
Migraine headaches
Head pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations