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Sponsors and Collaborators: |
University of California, San Francisco American Academy of Otolaryngology-Head and Neck Surgery Foundation |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00732108 |
The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.
Condition | Intervention |
---|---|
Migraine Headache Dizziness |
Drug: topiramate Drug: lactulose placebo pill |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness |
Estimated Enrollment: | 80 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
topiramate: Experimental
topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
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Drug: topiramate
50mg orally for 2 weeks, then 100mg orally for 6 weeks
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2: Placebo Comparator
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
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Drug: lactulose placebo pill
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
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Migraine is a common disorder, often associated with dizziness symptoms. In many cases, dizziness is one of the only manifestations of migraine headaches. Various classes of drugs have been advocated as treatment for migraine-associated dizziness, though none has been shown to be superior over the others.
Topiramate is a drug approved for migraine prophylaxis. This study is designed to assess if there are significant changes in dizziness frequency and severity in patients diagnosed with migraine-associated dizziness treated with topiramate. Demonstrating benefit of topiramate with a placebo-controlled study to alleviate symptoms of dizziness would serve to clarify effective treatment options for patients with migraine-associated dizziness.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lawrence R Lustig, M.D. | dizzy@headache.ucsf.edu | |
Contact: Harry S Hwang, M.D. | dizzy@headache.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Laura O'Neill 415-885-7861 ONeillL@neurology.ucsf.edu | |
Principal Investigator: Lawrence R Lustig, M.D. | |
Sub-Investigator: Harry S Hwang, M.D. | |
Sub-Investigator: Peter Goadsby, M.D., Ph.D. | |
Sub-Investigator: Abraham J Nagy, M.D. |
Principal Investigator: | Lawrence R Lustig, M.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Lawrence R. Lustig, M.D. ) |
Study ID Numbers: | H48626-32352-01 |
Study First Received: | August 7, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00732108 History of Changes |
Health Authority: | United States: Institutional Review Board |
migraine headache dizziness |
vertigo topiramate Topamax |
Sensation Disorders Dizziness Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Neuroprotective Agents Vertigo Headache Disorders |
Anti-Obesity Agents Signs and Symptoms Migraine Disorders Headache Neurologic Manifestations Topiramate Anticonvulsants Lactulose |
Sensation Disorders Dizziness Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions |
Headache Disorders Anti-Obesity Agents Signs and Symptoms Migraine Disorders Therapeutic Uses Headache Neurologic Manifestations Topiramate Central Nervous System Agents Anticonvulsants |