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Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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Purpose
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 |
|---|---|---|
| Migraine Headache | Drug: topiramate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00210821
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210821
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00210821 History of Changes |
| Other Study ID Numbers: |
CR004666 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 8, 2011 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
migraine headache analgesics prophylaxis prevention |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Topiramate Amitriptyline Amitriptyline, perphenazine drug combination Anticonvulsants Neuroprotective Agents |
Protective Agents Physiological Effects of Drugs Anti-Obesity Agents Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
ClinicalTrials.gov processed this record on July 18, 2017