A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine
1 other identifier
interventional
300
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2002
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 22, 2005
CompletedFirst Posted
Study publicly available on registry
April 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedAugust 2, 2012
August 1, 2012
3.9 years
April 22, 2005
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Northport, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Berkeley, California, United States
Unknown Facility
Golden, Colorado, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Brockton, Massachusetts, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Chaska, Minnesota, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
Bismarck, North Dakota, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Mogadore, Ohio, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Lake Jackson, Texas, United States
Unknown Facility
Richardson, Texas, United States
Unknown Facility
Alexandria, Virginia, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Middleton, Wisconsin, United States
Related Publications (1)
Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP; Study Group. Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial. Headache. 2009 Feb;49(2):216-26. doi: 10.1111/j.1526-4610.2008.01326.x.
PMID: 19222595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2005
First Posted
April 25, 2005
Study Start
March 1, 2002
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
August 2, 2012
Record last verified: 2012-08