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

March 4, 2015 updated by: University of California, San Francisco

Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: topiramate
topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
Drug: topiramate
50mg orally for 2 weeks, then 100mg orally for 6 weeks
Other Names:
  • Topamax
Placebo Comparator: 2
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Drug: lactulose placebo pill
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Other Names:
  • placebo pill

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Investigators

  • Principal Investigator: Lawrence R Lustig, M.D., University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H48626-32352-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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