A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache
- Conditions
- Migraine Headache
- Registration Number
- NCT00055484
- Lead Sponsor
- Elan Pharmaceuticals
- Brief Summary
The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
- Detailed Description
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:
1. Serotonergic or monoaminergic agents such as methysergide, which have demonstrated high degrees of effectiveness;
2. Non-serotonergic drugs such as beta-blockers, tricyclic antidepressants, valproate; and
3. Drugs with lesser demonstrated effectiveness, such as selective serotonin reuptake inhibitors, calcium channel antagonists, and non-steroidal anti-inflammatory drugs.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
University of South Alabama Medical Ctr Department of Neurology
🇺🇸Mobile, Alabama, United States
Valley Neurological Headache Clinic
🇺🇸Phoenix, Arizona, United States
The New England Center for Headache
🇺🇸Stamford, Connecticut, United States
Radiant Research
🇺🇸Salt Lake City, Utah, United States
Michigan Head-Pain & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Mercy Health Research
🇺🇸Chesterfield, Missouri, United States
Headache Care Center
🇺🇸Springfield, Missouri, United States
Neurological Associates of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Scroll for more (2 remaining)Medical Affiliated Research Center🇺🇸Huntsville, Alabama, United States