Status:
COMPLETED
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00210821
Start Date
February 1 2004
End Date
November 1 2005
Last Update
June 10 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.