An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the long-term safety and effectiveness of topiramate for the prevention of migraine headaches in adults. Topiramate has been approved to prevent migraine headaches in adults.

• 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:

• Diagnosis of migraine with or without aura

• Successfully finished CAPSS-277 study

• In generally good health

• Able to take medicine orally

• If female, using birth control

Exclusion Criteria:

• Not having a more painful condition than the headache pain

• Cannot be taking any other medications not allowed by the study

• Abnormal liver tests

• Not compliant with study medication during the CAPSS-277 study

• Pregnant or breast-feeding