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Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine; Headache; Dizziness

Intervention: topiramate (Drug); lactulose placebo pill (Drug)

Phase: N/A

Status: Withdrawn

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

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

University of California, San Francisco, San Francisco, California 94143, United States
Additional Information

Starting date: November 2008
Last updated: March 4, 2015

Page last updated: August 23, 2015

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