Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
This study has been withdrawn prior to enrollment.
(No subjects enrolled)
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
First received: August 7, 2008
Last updated: July 18, 2011
Last verified: July 2011
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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:
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:
|
Vestibular Diseases Dizziness Vertigo Headache Migraine Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms 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 May 16, 2013