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This study has been withdrawn prior to enrollment.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:
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

August 7, 2008
July 18, 2011
November 2008
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00732108 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Migraine
  • Headache
  • Dizziness
  • Drug: topiramate
    50mg orally for 2 weeks, then 100mg orally for 6 weeks
    Other Name: Topamax
  • Drug: lactulose placebo pill
    1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
    Other Name: placebo pill
  • Experimental: topiramate
    topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
    Intervention: Drug: topiramate
  • Placebo Comparator: 2
    1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
    Intervention: Drug: lactulose placebo pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
80
Not Provided
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00732108
H48626-32352-01
Yes
Lawrence R. Lustig, M.D., University of California, San Francisco
University of California, San Francisco
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Principal Investigator: Lawrence R Lustig, M.D. University of California, San Francisco
University of California, San Francisco
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP