A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams[mg], 100mg, and 200mg taken daily) compared with placebo in the prevention of migraine.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 6 months prior to the study

• Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase

• No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline

• Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

• Patients with headaches other than migraine

• Patients with episodic tension or sinus headaches

• Onset of migraine after age of 50 years

• Patients who have failed more than two adequate regimens for migraine prophylaxis

• Patients who overuse pain medications or certain other medications