Official Title: “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.

Study Type: Interventional

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

Study Primary Completion Date: October 2008

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.

Primary Measures

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

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

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

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