An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.

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

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Subjects must have an established history consistent with migraine, with or without aura, confirming to International Headache Society (HIS) criteria for at least 6 months prior to study entry

• must be using a stable dose of triptan for migraine treatment for at least 3 migraine attacks per month

• must have failed <=2 previous prophylactic medications due to lack of effectiveness

• must have had between 3 and 12 migraine periods and no more than 18 headache days (migraine and non-migraine) during the 6-week Prospective Baseline Period. (A headache day is defined as a calendar day which the subject experienced headache pain for at least 4 hours untreated, or 30 minutes duration treated)

• female subjects who are postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 1.

Exclusion Criteria:

• Subjects with headaches other than migraine with and/or without aura

• onset of migraine after age 50

• overuse analgesics or specific medications for treatment of migraine attacks

• currently on a prophylactic medication for migraine

• history of an unstable medical condition within the past 2 years, malignancy within the past 5 years, major psychiatric disorder within the past 6 months, suicidal ideations or suicide attempt within the past 2 years or history of alcohol or drug abuse within the past 6 months