Status:
COMPLETED
An Open Label Extension of a Study of Topiramate in Chronic Migraine.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mig...
Detailed Description
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00210873
Start Date
February 1 2004
End Date
August 1 2005
Last Update
June 10 2011
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