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

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Dizziness; Migraine; Headache

Treatments: Drug: lactulose placebo pill; Drug: topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT00732108

H48626-32352-01

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

topiramate

Experimental group

Description:

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

Treatment:

Drug: topiramate

2

Placebo Comparator group

Description:

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

Treatment:

Drug: lactulose placebo pill