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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00360282
First received: August 2, 2006
Last updated: December 23, 2009
Last verified: December 2009
History of Changes

August 2, 2006
December 23, 2009
August 2006
January 2009   (final data collection date for primary outcome measure)
Motion Sickness Scores [ Time Frame: Prospective ] [ Designated as safety issue: No ]
Motion Sickness Scores
Complete list of historical versions of study NCT00360282 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

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

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.
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Migraine
  • Drug: Rizatriptan
    10 mg Rizatriptan in an unlabeled pill given once on one of two visits
    Other Name: Maxalt
  • Other: Placebo
    In an unlabeled pill given once on one of two visits.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
March 2010
January 2009   (final data collection date for primary outcome measure)

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 ear, nose and throat (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 Monamine Oxidase (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
Both
21 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360282
0602009, Merck31449
No
Dr. Joseph Furman, University of Pittsburgh
University of Pittsburgh
Merck
Principal Investigator: Joseph M Furman, MD, PhD University of Pittsburgh
University of Pittsburgh
December 2009

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