Status:
COMPLETED
An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.
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 migraine headaches in adults. Topiramate has been approved to prevent migraine headach...
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 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00210860
Start Date
September 1 2004
End Date
March 1 2006
Last Update
June 10 2011
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