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

University of California, San Francisco

Overview

The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Migraine Headache Dizziness

Interventions

topiramateDRUG

50mg orally for 2 weeks, then 100mg orally for 6 weeks

lactulose placebo pillDRUG

1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in mean 28-day monthly vertigo frequency from baseline.

Time frame: 4 weeks, 8 weeks

Change in Dizziness Handicap Inventory scores from baseline.

Time frame: 4 weeks, 8 weeks

Secondary Outcomes

Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.

Time frame: 4 weeks, 8 weeks

Data from ClinicalTrials.gov

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