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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Joseph Furman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00360282
First received: August 2, 2006
Last updated: December 4, 2014
Last verified: December 2014

August 2, 2006
December 4, 2014
August 2006
January 2009   (final data collection date for primary outcome measure)
Change From Baseline in Motion Sickness to Post Vestibular Stimulus [ Time Frame: Pre and Post Stimulus (about 6 minutes apart) ] [ Designated as safety issue: No ]
Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.
Motion Sickness Scores
Complete list of historical versions of study NCT00360282 on ClinicalTrials.gov Archive Site
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus [ Time Frame: Pre and Post Stimulus (6 minutes apart) ] [ Designated as safety issue: No ]
Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.
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 and were excluded if there were clinically significant abnormalities. Following screening, there were 2 experimental visits in which migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the drug, subjects were idle for 2 hours. Baseline motion sickness and subjective units of distress levels were assessed prior to undergoing sinusoidal-earth-vertical earth axis rotation in darkness at 0.05 Hz. Scores were taken immediately after stopping. Subjects were given a 2 minutes rest and then underwent a motion sickness provoking rotation. Subjective scores were assessed immediately following. Another two minute rest was given and if the subject was able, underwent a second motion sickness provoking stimulus followed by an assessment.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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.
    Other Name: Sugar Pill
  • With Vertigo; Placebo - Rizatriptan
    This group received placebo on visit 1 and Rizatriptan on visit 2.
    Interventions:
    • Drug: Rizatriptan
    • Other: Placebo
  • With Vertigo; Rizatriptan - Placebo
    These subjects received Rizatriptan on visit 1 and placebo on visit 2.
    Interventions:
    • Drug: Rizatriptan
    • Other: Placebo
  • Without Vertigo; Placebo - Rizatriptan
    This group received placebo on visit 1 and Rizatriptan on visit 2.
    Interventions:
    • Drug: Rizatriptan
    • Other: Placebo
  • Without Vertigo; Rizatriptan-Placebo
    This group received Rizatriptan on visit 1 and placebo on visit 2.
    Interventions:
    • Drug: Rizatriptan
    • Other: Placebo
Furman JM, Marcus DA, Balaban CD. Rizatriptan reduces vestibular-induced motion sickness in migraineurs. J Headache Pain. 2011 Feb;12(1):81-8. doi: 10.1007/s10194-010-0250-z. Epub 2010 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360282
0602009, 31449
No
Not Provided
Not Provided
Joseph Furman, University of Pittsburgh
University of Pittsburgh
Merck Sharp & Dohme Corp.
Principal Investigator: Joseph M Furman, MD, PhD University of Pittsburgh
University of Pittsburgh
December 2014

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