Back to resultsComparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
Primary Purpose
Migraine, Headache
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
topiramate
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring migraine, headache, analgesics, prophylaxis, prevention
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline in the average monthly migraine episode rate.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00210821
First Posted
September 13, 2005
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00210821
Brief Title
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
Official Title
A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache
Keywords
migraine, headache, analgesics, prophylaxis, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
topiramate
Primary Outcome Measure Information:
Title
Change from baseline in the average monthly migraine episode rate.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=617&filename=CR004666_CSR.pdf
Description
Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis
Learn more about this trial
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
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