Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis
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.
Study Overview
Detailed Description
People who suffer from migraines have many prescription medications to choose from, both to treat the migraine and to prevent it from starting.
However, many patients have not had success in finding the drug that helps them best.
Amitriptyline, an antidepressant, has been used successfully for many years to prevent migraine headaches.
This study will compare the effectiveness of amitriptyline with the effectiveness of topiramate, an anti-seizure drug, in preventing migraines.
The safety of both drugs will also be assessed.
The objective of the study is to demonstrate that topiramate will be at least as effective as amitriptyline in preventing migraines.
During the first 4 weeks of the study, topiramate or amitriptyline will be increased by 25 mg per week up to a total dose of 100 mg per day or up to the maximum tolerated dose, whichever is less.
Treatment will continue at 100 mg per day for 22 weeks.
Study Type
Interventional
Enrollment (Actual)
347
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in the average monthly migraine episode rate.
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Secondary Outcome Measures
Outcome Measure |
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Change in average monthly rate of days with migraine headache; change in average monthly rate of headache (migraine & non-migraine) days; change in average monthly rate of acute abortive medications; weight changes; quality of life assessments
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004666
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.