An Open Label Extension of a Study of Topiramate in Chronic Migraine.

• Status: Completed
• Trial end date: 2005-08-01
• 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 headaches in adults with chronic migraine. Topiramate has been approved 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: Topiramate

Criteria

Inclusion Criteria:

• Diagnosis of chronic migraine

• successfully finished double-blind portion of the CAPSS-276 study or discontinued the study after a minimum of 4 weeks maintenance treatment due to lack of effect of study drug

• in generally good health

• able to take medicine orally

• if female, using birth control.

Exclusion Criteria:

• Cannot have a more painful condition than the headache pain

• cannot be taking any other medications not allowed by the study protocol

• no abnormal liver tests

• not compliant with study medication during the CAPSS-276 study

• cannot be pregnant or breast-feeding.