A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The study will also assess dose response relationship of topiramate, estimate the relative efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect of migraine prevention with topiramate versus placebo on Health Related Quality of Life.

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

Details

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

Criteria

Inclusion Criteria:

• Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year 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