Overview

This trial is active, not recruiting.

Condition migraine
Treatments rizatriptan, placebo
Phase phase 0
Sponsor University of Pittsburgh
Collaborator Merck Sharp & Dohme Corp.
Start date August 2006
End date January 2009
Trial size 25 participants
Trial identifier NCT00360282, 0602009, Merck31449

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose prevention

Primary Outcomes

Measure
Motion Sickness Scores
time frame: Prospective

Eligibility Criteria

Male or female participants from 21 years up to 45 years old.

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

Additional Information

Official title Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
Principal investigator Joseph M Furman, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by University of Pittsburgh.