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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.

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.