A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
Phase 2
Completed
- Conditions
- Migraine Headaches
- Registration Number
- NCT00109083
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
- Secondary Outcome Measures
Name Time Method