- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00732108
Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: topiramate
topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks
|
50mg orally for 2 weeks, then 100mg orally for 6 weeks
Other Names:
|
Placebo Comparator: 2
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
|
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mean 28-day monthly vertigo frequency from baseline.
Time Frame: 4 weeks, 8 weeks
|
4 weeks, 8 weeks
|
Change in Dizziness Handicap Inventory scores from baseline.
Time Frame: 4 weeks, 8 weeks
|
4 weeks, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
Time Frame: 4 weeks, 8 weeks
|
4 weeks, 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lawrence R Lustig, M.D., University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Vestibular Diseases
- Sensation Disorders
- Headache Disorders, Primary
- Headache Disorders
- Vertigo
- Dizziness
- Migraine Disorders
- Headache
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Anticonvulsants
- Lactulose
- Topiramate
Other Study ID Numbers
- H48626-32352-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
CoolTech LLCObvioHealthRecruitingMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
Clinical Trials on topiramate
-
Johnson & Johnson Taiwan LtdCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Supernus Pharmaceuticals, Inc.Completed
-
University of CopenhagenR W Johnson Pharmaceutical Research InstituteTerminated
-
Montefiore Medical CenterOrtho-McNeil PharmaceuticalCompletedObsessive-compulsive DisorderUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho-McNeil Neurologics, Inc.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho-McNeil Neurologics, Inc.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho-McNeil Neurologics, Inc.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...TerminatedObesity | Hypertriglyceridemia | Hyperlipidemia
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedEpilepsy | Seizures | Epilepsies, Partial