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Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?

This study is currently recruiting participants.
Verified by University of Pittsburgh, February 2008

Sponsors and Collaborators: University of Pittsburgh
Merck
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00360282
  Purpose

The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.


Condition Intervention Phase
Migraine
Drug: Rizatriptan
Phase 0

Genetics Home Reference related topics:   familial hemiplegic migraine   

MedlinePlus related topics:   Migraine    Motion Sickness   

ChemIDplus related topics:   Rizatriptan Benzoate    Rizatriptan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Motion Sickness Scores [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Estimated Enrollment:   25
Study Start Date:   August 2006
Estimated Study Completion Date:   January 2009
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Rizatriptan
    10 mg Rizatriptan or Placebo as a blind pill; each given once on either experimental visit
Detailed Description:

Migraine sufferers undergo vestibular tests to note abnormalities. There are 2 experimental visits in which migraine sufferers are given either the Rizatriptan or a fake pill and then are asked to rotate in a chair that is tilted. Motion sickness scores are taken throughout testing.

  Eligibility
Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • History of Motion Sickness
  • Currently suffering from migraines with at least 2 episodes during the previous 12 months
  • Previous use and tolerance to triptans

Exclusion Criteria:

  • Current tobacco user
  • History of or current hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
  • Family history of early myocardial infarction (first-degree relative < 45 years old at time of event)
  • Constant dizziness or constant vestibular symptoms
  • History of ENT disease, e.g. Meniere's disease
  • Current treatment with propranolol or medications that would preclude use of a triptan(e.g. ergotamine)
  • Major vestibular abnormality found on screening
  • Testing positive on over-the-counter pregnancy test
  • Taken an MAO inhibitor within two weeks of testing
  • Allergy or intolerance to gelatin
  • Corrected visual acuity of > 20/40 O.U.
  • Women who are pregnant or breastfeeding
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360282

Contacts
Contact: Susan Strelinski     (412) 647-8088     strelinskisb@upmc.edu    
Contact: Anita Lieb, MS, CCRC     (412) 647-8087     alieb@pitt.edu    

Locations
United States, Pennsylvania
University of Pittsburgh     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Principal Investigator: Joseph M Furman, MD, PhD            
      Sub-Investigator: Dawn Marcus, MD            

Sponsors and Collaborators
University of Pittsburgh
Merck

Investigators
Principal Investigator:     Joseph M Furman, MD, PhD     University of Pittsburgh    
  More Information

Responsible Party:   University of Pittsburgh ( Dr. Joseph Furman )
Study ID Numbers:   0602009, Merck31449
First Received:   August 2, 2006
Last Updated:   February 6, 2008
ClinicalTrials.gov Identifier:   NCT00360282
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Migraine  
Vertigo  
Motion Sickness  

Study placed in the following topic categories:
Migraine Disorders
Headache
Central Nervous System Diseases
Disorders of Environmental Origin
Headache Disorders, Primary
Rizatriptan
Motion Sickness
Brain Diseases
Serotonin
Vertigo
Headache Disorders

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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