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

Sponsors and Collaborators:	University of California, San Francisco American Academy of Otolaryngology-Head and Neck Surgery Foundation
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00732108

Purpose

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

Condition	Intervention
Migraine Headache Dizziness	Drug: topiramate Drug: lactulose placebo pill

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Dizziness and Vertigo Headache Migraine

Drug Information available for: Topiramate Lactulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Change in mean 28-day monthly vertigo frequency from baseline. [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
Change in Dizziness Handicap Inventory scores from baseline. [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale. [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
topiramate: Experimental 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
2: Placebo Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732108

Contacts

Contact: Lawrence R Lustig, M.D.		dizzy@headache.ucsf.edu
Contact: Harry S Hwang, M.D.		dizzy@headache.ucsf.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Laura O'Neill 415-885-7861 ONeillL@neurology.ucsf.edu
Principal Investigator: Lawrence R Lustig, M.D.
Sub-Investigator: Harry S Hwang, M.D.
Sub-Investigator: Peter Goadsby, M.D., Ph.D.
Sub-Investigator: Abraham J Nagy, M.D.

Sponsors and Collaborators

University of California, San Francisco

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Investigators

Principal Investigator:

Lawrence R Lustig, M.D.

University of California, San Francisco

More Information

Responsible Party:	University of California, San Francisco ( Lawrence R. Lustig, M.D. )
Study ID Numbers:	H48626-32352-01
Study First Received:	August 7, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00732108
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

migraine
headache
dizziness

vertigo
topiramate
Topamax

Study placed in the following topic categories:

Sensation Disorders
Dizziness
Central Nervous System Diseases
Pain
Headache Disorders, Primary
Brain Diseases
Vertigo

Headache Disorders
Signs and Symptoms
Migraine Disorders
Headache
Neurologic Manifestations
Topiramate
Lactulose

Additional relevant MeSH terms:

Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009