Dizziness, Headache, Migraine
Conditions
Keywords
migraine, headache, dizziness, vertigo, topiramate, Topamax
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.
Interventions
DRUGtopiramate
50mg orally for 2 weeks, then 100mg orally for 6 weeks
DRUGlactulose placebo pill
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Sponsors
American Academy of Otolaryngology-Head and Neck Surgery Foundation
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale. | 4 weeks, 8 weeks |
Countries
United States
Outcome results
None listed