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Sponsors and Collaborators: |
Monarch Medical Research Ortho-McNeil Neurologics, Inc. |
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Information provided by: | Monarch Medical Research |
ClinicalTrials.gov Identifier: | NCT00131443 |
The objective of this study is to assess the effectiveness and safety of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.
Condition | Intervention | Phase |
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Basilar Migraine |
Drug: Topiramate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine |
Estimated Enrollment: | 40 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | August 2006 |
The objective of this study is to assess the efficacy and safety of topiramate in the prophylaxis of basilar migraine and hemiplegic migraine in children and adolescents, by comparing two doses, 25 and 100 mg/day.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, subjects must:
If (b) or (c), the subject must have a negative urine pregnancy test within one week of study entry.
Willing and able to:
Exclusion Criteria:
Overuse analgesic or migraine-specific agents for abortive treatment of migraine:
United States, Virginia | |
Monarch Medical Research - Child and Adolescent Neurology | |
Norfolk, Virginia, United States, 23510 |
Principal Investigator: | Donald W Lewis, MD | Monarch Medical Research |
Study ID Numbers: | CAPSS 271 |
Study First Received: | August 15, 2005 |
Last Updated: | November 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00131443 |
Health Authority: | United States: Institutional Review Board |
Basilar/Hemiplegic Migraine Prophylaxis |
Basilar artery migraines Migraine Disorders Headache Topiramate Central Nervous System Diseases |
Headache Disorders, Primary Migraine with Aura Brain Diseases Headache Disorders |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |