A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the effectiveness and safety of topiramate (an epilepsy medication) 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.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Meet the criteria of the International Headache Society for the classification of migraine with or without aura (migraine symptoms)

• Diagnosis of migraine for at least 12 months prior to start of the study

• Have had an average of 3 to 8 migraine attacks per month for the 3 months prior to the start of the study

• Ability to recognize migraine headaches and to distinguish them from tension-type headaches or other types of head pain

• General good health

Exclusion Criteria:

• Patients who previously failed to respond to topiramate therapy for migraine prevention or who discontinued topiramate due to adverse events

• Patients who had onset of migraine after age 50

• Patients having more than 15 headache-days per month during the 3 months prior to start of the study, or during the baseline (pretreatment) period

• Patients who have cluster headaches or who have exclusively aura (migraine symptoms) without headache

• Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children