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

Sponsor:	University of California, San Francisco
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine Ménière disease

MedlinePlus related topics: Dizziness and Vertigo Headache Migraine

Drug Information available for: Topiramate Lactulose

U.S. FDA Resources

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:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: placebo pill

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

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143

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

No publications provided

Responsible Party:	Lawrence R. Lustig, M.D., University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00732108 History of Changes
Other Study ID Numbers:	H48626-32352-01
Study First Received:	August 7, 2008
Last Updated:	July 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

migraine
headache
dizziness

vertigo
topiramate
Topamax

Additional relevant MeSH terms:

Dizziness
Vertigo
Headache
Migraine Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Pain
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Contraceptives, Oral
Lactulose
Topiramate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Gastrointestinal Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on February 09, 2012