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: February 6, 2008

Verified by: University of Pittsburgh, February 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):

Intervention(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

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.

Outcome Measures for this Clinical Trial

Primary:

  • Motion Sickness Scores Prospective 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 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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: University of Pittsburgh

University of Pittsburgh

Pittsburgh Pennsylvania 15213 United States

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 23, 2008

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

Study ID Number: 0602009

ClinicalTrials.gov Identifier: NCT00360282

Health Authority: United States: Food and Drug Administration

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.