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| Sponsored by: |
Elan Pharmaceuticals |
|---|---|
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00055484 |
Purpose
The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headache |
Drug: zonisamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Randomized, Multicenter, Parallel Dose Study to Evaluate the Safety and Efficacy of Zonisamide 150 Mg and 300 Mg Per Day and Placebo in Subjects With Migraine Headache |
| Estimated Enrollment: | 204 |
| Study Start Date: | March 2002 |
The pharmacologic treatment of migraine may be acute (abortive, symptomatic) or preventive (prophylactic). Preventive medication is usually given daily for months or years; however, treatment may also be given in an intermittent regimen. Most migraine prophylactic medications were designed to treat other disorders, and they can be divided into three groups:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION:
Subjects who meet all the following criteria will be eligible to participate in the study:
EXCLUSION:
Subjects meeting any of the following criteria will not be eligible to participate in this study:
Contacts and Locations| United States, Alabama | |
| University of South Alabama Medical Ctr Department of Neurology | |
| Mobile, Alabama, United States, 36693 | |
| Medical Affiliated Research Center | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Valley Neurological Headache Clinic | |
| Phoenix, Arizona, United States, 85020 | |
| United States, Connecticut | |
| The New England Center for Headache | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Kansas | |
| Radiant Research | |
| Overland Park, Kansas, United States, 66215 | |
| United States, Michigan | |
| Michigan Head-Pain & Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Missouri | |
| Headache Care Center | |
| Springfield, Missouri, United States, 65804 | |
| Mercy Health Research | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Oklahoma | |
| Neurological Associates of Tulsa | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| MetaClin Research | |
| Austin, Texas, United States, 19107 | |
| Houston Headache Clinic | |
| Houston, Texas, United States, 77004 | |
| United States, Utah | |
| Radiant Research | |
| Salt Lake City, Utah, United States, 84111 | |
More Information
| Study ID Numbers: | AN46046-228 |
| Study First Received: | March 3, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00055484 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Headache prophylaxis AED migraine prophylaxis |
|
Signs and Symptoms Antioxidants Migraine Disorders Zonisamide Headache Central Nervous System Diseases |
Neurologic Manifestations Headache Disorders, Primary Pain Brain Diseases Anticonvulsants Headache Disorders |
|
Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Zonisamide Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Protective Agents |
Pharmacologic Actions Headache Disorders Signs and Symptoms Migraine Disorders Therapeutic Uses Headache Neurologic Manifestations Central Nervous System Agents Anticonvulsants |