Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis

Conditions
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Migraine, Headache

Intervention / Treatment
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* Drug: topiramate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topiramate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the average monthly migraine episode rate. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, analgesics, prophylaxis, prevention