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| 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 |
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 III |
| 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 |
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| ClinicalTrials.gov 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 |
|
migraine headache analgesics prophylaxis prevention |
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Amitriptyline Amitriptyline, perphenazine drug combination Topiramate Antidepressive Agents, Tricyclic Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antipsychotic Agents |
