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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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:
The choice of treatment must be individualized, and is influenced by contraindications, potential side effects, the need to treat associated symptoms like tension-type headache and insomnia, and drug cost.
Anticonvulsants, such as valproate, have shown significant degrees of efficacy in migraine prophylaxis when used in low doses. Considering the differences in proposed mechanisms of action of these agents, it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine.
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 | |
| Medical Affiliated Research Center | |
| Huntsville, Alabama, United States, 35801 | |
| University of South Alabama Medical Ctr Department of Neurology | |
| Mobile, Alabama, United States, 36693 | |
| 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 | |
| Mercy Health Research | |
| Chesterfield, Missouri, United States, 63017 | |
| Headache Care Center | |
| Springfield, Missouri, United States, 65804 | |
| 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
| ClinicalTrials.gov Identifier: | NCT00055484 History of Changes |
| Other Study ID Numbers: | AN46046-228 |
| Study First Received: | March 3, 2003 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Migraine Headache prophylaxis AED migraine prophylaxis |
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Zonisamide Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Anticonvulsants Central Nervous System Agents Therapeutic Uses |