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

Migraine Clinical Trial

Official title:

Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00732108
• Other study ID #: H48626-32352-01
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2008
• Last updated: March 4, 2015
• Start date: November 2008

Study information

• Verified date: March 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Headache
• Migraine
• Migraine Disorders
• Vertigo

Intervention

Drug:
• topiramate
50mg orally for 2 weeks, then 100mg orally for 6 weeks
• lactulose placebo pill
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Academy of Otolaryngology-Head and Neck Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean 28-day monthly vertigo frequency from baseline.		4 weeks, 8 weeks	No
Primary	Change in Dizziness Handicap Inventory scores from baseline.		4 weeks, 8 weeks	No
Secondary	Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.		4 weeks, 8 weeks	No