Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of two treatment regimens in preventing migraines. The antidepressant amitriptyline has been used successfully to prevent migraine headaches.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Topiramate

Criteria

Inclusion Criteria:

• Migraine headache for at least 6 months, with 3 to 12 headaches a month for the previous 3 months

• no more than 15 headache days in the previous month before study start

• no heart rhythm problems or neurologic problems

• women must not be pregnant and must use birth control

Exclusion Criteria:

• Cannot have failed at least 2 previous trials of migraine prevention drugs

• cannot have failed a previous trial of topiramate or amitriptyline

• no cluster headaches

• no migraine with aura without headache

• no pain that is worse than the migraine pain