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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
- Study Primary Completion Date: January 2009
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
- Time Frame: Prospective
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 Investigator Information
Lead Investigator: University of Pittsburgh Other
Overall Clinical Trial Officials and Contacts
Joseph M Furman, MD, PhD Principal Investigator University of Pittsburgh
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00360282
