The Prolonged Use of Topiramate for Preventing Migraine Headaches

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Established history of migraine for at least one year;

• Migraine meets HIS (International Headache Society) criteria

• An average of at least 4 monthly migraine days during the 3 months preceding trial entry

• Capable of keeping trial records; Exclusion Criteria:

• Patient used migraine prophylactic medication in the month prior to trial entry (flunarizine: 3 months prior to entry)

• Patient had failed (lack of efficacy) more than two adequate previous regimens of migraine prophylactic medications

• Patient had a history of severe drug allergy or hypersensitivity

• Patient overused analgesics, opiates, ergots and/or triptans

• Patient had been using topiramate regularly