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

NCT ID: NCT00732108

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30

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.

Conditions

Migraine; Headache; Dizziness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

topiramate

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

Group Type: EXPERIMENTAL

topiramate

Intervention Type: DRUG

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

2

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

Group Type: PLACEBO_COMPARATOR

lactulose placebo pill

Intervention Type: DRUG

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

Interventions

topiramate

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

Intervention Type: DRUG

lactulose placebo pill

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

Intervention Type: DRUG

Other Intervention Names

Topamax; placebo pill

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Otolaryngology-Head and Neck Surgery Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California, San Francisco

Principal Investigators

Lawrence R Lustig, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

H48626-32352-01

Identifier Type: -

Identifier Source: org_study_id