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

Not Applicable

Withdrawn

• Conditions: Migraine; Dizziness; Headache
• Interventions: Drug: lactulose placebo pill; Drug: topiramate

• Registration Number: NCT00732108
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Study Start: 2008-11
• Primary Completion: 2011-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	lactulose placebo pill	1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
topiramate	topiramate	topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change in Dizziness Handicap Inventory scores from baseline.	4 weeks, 8 weeks
Change in mean 28-day monthly vertigo frequency from baseline.	4 weeks, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.	4 weeks, 8 weeks

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States