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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210821
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: May 2010

September 13, 2005
June 8, 2011
February 2004
Not Provided
Change from baseline in the average monthly migraine episode rate.
Same as current
Complete list of historical versions of study NCT00210821 on ClinicalTrials.gov Archive Site
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
  • 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
Not Provided
Not Provided
 
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Migraine
  • Headache
Drug: topiramate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
347
November 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00210821
CR004666
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP