Official Title: “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 Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

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 amitripyline 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.

Intervention(s) in this Clinical Trial

• Drug: topiramate

Primary Measures

• Change from baseline in the average monthly migraine episode rate.

Secondary Measures

• Change in the average monthly rate of days with migraine headache
• change in the average monthly rate of headache (migraine & non-migraine) days; change in the average monthly rate of acute abortive medications; weight changes; quality of life assessments

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00210821

Study ID Number: CR004666

ClinicalTrials.gov Identifier: NCT00210821

Health Authority: United States: Food and Drug Administration

Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis