Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis|
- Change from baseline in the average monthly migraine episode rate.
- 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
|Study Start Date:||February 2004|
|Study Completion Date:||November 2005|
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 Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|