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
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