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

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

Date First Received: August 2, 2006

Last Updated: October 10, 2008

Verified by: University of Pittsburgh, October 2008

Clinical Trial Phase: N/A | Start Date: August 2006

Overall Status: Recruiting

Estimated Enrollment: 25

Brief Summary

Official Title: “Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs”

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: October 2008

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Rizatriptan
    • 10 mg Rizatriptan in an unlabeled pill given once on one of two visits
  • Other: Placebo
    • In an unlabeled pill given once on one of two visits.

Outcome Measures for this Clinical Trial

Primary Measures

  • Motion Sickness Scores
    • Time Frame: Prospective
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Joseph M Furman, MD, PhD Principal Investigator University of Pittsburgh  

Overall Contact: Susan Strelinski (412) 647-8088 strelinskisb@upmc.edu

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00360282

Study ID Number: 0602009

ClinicalTrials.gov Identifier: NCT00360282

Health Authority: United States: Institutional Review Board

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