|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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 |
|---|---|---|
|
Headache Migraine |
Drug: topiramate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
| Official Title: | A Comparison of Topiramate Versus Amitriptyline in Migraine Prophylaxis |
| Estimated Enrollment: | 330 |
| 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 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.
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 and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR004666 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00210821 |
| Health Authority: | United States: Food and Drug Administration |
|
prevention headache analgesics migraine prophylaxis |
|
Signs and Symptoms Migraine Disorders Headache Amitriptyline Topiramate Central Nervous System Diseases |
Neurologic Manifestations Headache Disorders, Primary Pain Brain Diseases Headache Disorders |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Protective Agents Neuroprotective Agents Pharmacologic Actions |
Antidepressive Agents, Tricyclic Anti-Obesity Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Antidepressive Agents |
