Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
Primary Purpose
Migraine, Headache, Dizziness
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
topiramate
lactulose placebo pill
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine, headache, dizziness, vertigo, topiramate, Topamax
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
topiramate
2
Arm Description
topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Outcomes
Primary Outcome Measures
Change in mean 28-day monthly vertigo frequency from baseline.
Change in Dizziness Handicap Inventory scores from baseline.
Secondary Outcome Measures
Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
Full Information
NCT ID
NCT00732108
First Posted
August 7, 2008
Last Updated
March 4, 2015
Sponsor
University of California, San Francisco
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00732108
Brief Title
Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
Official Title
Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
Collaborators
American Academy of Otolaryngology-Head and Neck Surgery Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache, Dizziness
Keywords
migraine, headache, dizziness, vertigo, topiramate, Topamax
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
topiramate
Arm Type
Experimental
Arm Description
topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
topiramate
Other Intervention Name(s)
Topamax
Intervention Description
50mg orally for 2 weeks, then 100mg orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
lactulose placebo pill
Other Intervention Name(s)
placebo pill
Intervention Description
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Primary Outcome Measure Information:
Title
Change in mean 28-day monthly vertigo frequency from baseline.
Time Frame
4 weeks, 8 weeks
Title
Change in Dizziness Handicap Inventory scores from baseline.
Time Frame
4 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
Time Frame
4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence R Lustig, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
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Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
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