A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Diagnosis of chronic migraine

• >=15 headache days per month in past 30 days

• >= 15 headache days, half of which need to be migraine headaches during the prospective baseline period

• MIDAS test score >= 11 at Visit 1

• In generally good health

• If female, using birth control

• No abnormalities on neurological examination

Exclusion Criteria:

• Failed > 2 adequate trials of migraine prevention medications

• Failed topiramate due to lack of effectiveness or adverse events

• Daily headaches of severe intensity during past 30 days

• Cluster, basilar, ophthalmoplegic, or hemiplegic migraines

• Migraines started after age 50

• Other pain greater than migraine pain

• Use of drugs to treat migraines for > 4 days per week during the past month