Back to resultsA Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
Primary Purpose
Migraine Headaches
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RWJ-333369
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headaches focused on measuring Migraine, Headaches, Migraine headaches, Head pain
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00109083
Brief Title
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headaches
Keywords
Migraine, Headaches, Migraine headaches, Head pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RWJ-333369
Primary Outcome Measure Information:
Title
Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Northport
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Berkeley
State/Province
California
Country
United States
City
Golden
State/Province
Colorado
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Brockton
State/Province
Massachusetts
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Chaska
State/Province
Minnesota
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Bismarck
State/Province
North Dakota
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Mogadore
State/Province
Ohio
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Lake Jackson
State/Province
Texas
Country
United States
City
Richardson
State/Province
Texas
Country
United States
City
Alexandria
State/Province
Virginia
Country
United States
City
Olympia
State/Province
Washington
Country
United States
City
Middleton
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19222595
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
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