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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: | NCT00158002 |
The objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.
Condition | Intervention | Phase |
---|---|---|
Basilar Migraine |
Drug: Topiramate |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine |
Estimated Enrollment: | 40 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | August 2006 |
This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase, Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 299 |
Study First Received: | September 7, 2005 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00158002 |
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 |