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

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00732108

Collaborator

American Academy of Otolaryngology-Head and Neck Surgery Foundation (Other)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Headache Dizziness	Drug: topiramate Drug: lactulose placebo pill	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

Study Start Date :

Nov 1, 2008

Anticipated Primary Completion Date :

Aug 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.