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

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

Detailed Description
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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.

Official Title
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Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

Conditions
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Migraine, Headache, Dizziness

Intervention / Treatment
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* Drug: topiramate
* Drug: lactulose placebo pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topiramate<br>topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks | Drug: topiramate<br>* 50mg orally for 2 weeks, then 100mg orally for 6 weeks<br>* Other names: Topamax;|
| Placebo Comparator: 2<br>1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks | Drug: lactulose placebo pill<br>* 1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks<br>* Other names: placebo pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean 28-day monthly vertigo frequency from baseline. |  | 4 weeks, 8 weeks | 
| Change in Dizziness Handicap Inventory scores from baseline. |  | 4 weeks, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale. |  | 4 weeks, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, dizziness, vertigo, topiramate, Topamax