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

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

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.

Condition Intervention Phase
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis

Resource links provided by NLM:

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Enrollment: 347
Study Start Date: February 2004
Study Completion Date: November 2005
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00210821

Sponsors and Collaborators
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.
  More Information

Additional Information:
No publications provided Identifier: NCT00210821     History of Changes
Other Study ID Numbers: CR004666
Study First Received: September 13, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics, Non-Narcotic
Anti-Obesity Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Psychotropic Drugs processed this record on October 13, 2015