Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine; Headache; Dizziness
Intervention: topiramate (Drug); lactulose placebo pill (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Lawrence R Lustig, M.D., Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Lawrence R Lustig, M.D., Email: dizzy@headache.ucsf.edu
Summary
The purpose of this study is to determine whether topiramate effective in treating dizziness
symptoms that are associated with migraine headaches.
Clinical Details
Official title: Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Change in mean 28-day monthly vertigo frequency from baseline.Change in Dizziness Handicap Inventory scores from baseline.
Secondary outcome: Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of migraine-associated dizziness.
Exclusion Criteria:
- Previous or current use of topiramate prior to study enrollment.
- Need for continued use of the following medications for any medical reason during the
study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine
oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local
anesthetics, botulinum toxin, or herbal preparations.
- History of nephrolithiasis.
- Women whom are pregnant or breastfeeding.
- Patients with known sensitivity to topiramate.
- Patients with a history of glaucoma.
- Patients with severe medical condition(s) that in the view of the investigator
prohibits participation in the study.
Locations and Contacts
Lawrence R Lustig, M.D., Email: dizzy@headache.ucsf.edu
University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
Laura O'Neill, Phone: 415-885-7861, Email: ONeillL@neurology.ucsf.edu
Lawrence R Lustig, M.D., Principal Investigator
Harry S Hwang, M.D., Sub-Investigator
Peter Goadsby, M.D., Ph.D., Sub-Investigator
Abraham J Nagy, M.D., Sub-Investigator
Additional Information
Starting date: November 2008
Last updated: February 17, 2009
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