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

NCT00732108 | Withdrawn DMC

• 1 other identifier: H48626-32352-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine; Headache; Dizziness

Keywords

migraine; headache; dizziness; vertigo; topiramate; Topamax

Outcome Measures

Primary Outcomes (2)

• Change in mean 28-day monthly vertigo frequency from baseline.

  4 weeks, 8 weeks

• Change in Dizziness Handicap Inventory scores from baseline.

  4 weeks, 8 weeks

Secondary Outcomes (1)

• Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.

  4 weeks, 8 weeks

Study Arms (2)

topiramate

EXPERIMENTAL

topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks

Drug: topiramate

2

PLACEBO COMPARATOR

1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks

Drug: lactulose placebo pill

Interventions

topiramate DRUG

50mg orally for 2 weeks, then 100mg orally for 6 weeks

Also known as: Topamax

topiramate

lactulose placebo pill DRUG

1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks

Also known as: placebo pill

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of migraine-associated dizziness.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Academy of Otolaryngology-Head and Neck Surgery Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Dizziness; Vertigo

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Lawrence R Lustig, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)