Clinical Trial: Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

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

Detailed Summary: Migraine sufferers undergo vestibular tests and were excluded if there were clinically significant abnormalities. Following screening, there were 2 experimental visits in which migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the drug, subjects were idle for 2 hours. Baseline motion sickness and subjective units of distress levels were assessed prior to undergoing sinusoidal-earth-vertical earth axis rotation in darkness at 0.05 Hz. Scores were taken immediately after stopping. Subjects were given a 2 minutes rest and then underwent a motion sickness provoking rotation. Subjective scores were assessed immediately following. Another two minute rest was given and if the subject was able, underwent a second motion sickness provoking stimulus followed by an assessment.
Sponsor: University of Pittsburgh

Current Primary Outcome: Change From Baseline in Motion Sickness to Post Vestibular Stimulus [ Time Frame: Pre and Post Stimulus (about 6 minutes apart) ]

Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.


Original Primary Outcome: Motion Sickness Scores

Current Secondary Outcome: Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus [ Time Frame: Pre and Post Stimulus (6 minutes apart) ]

Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.


Original Secondary Outcome:

Information By: University of Pittsburgh

Dates:
Date Received: August 2, 2006
Date Started: August 2006
Date Completion:
Last Updated: December 4, 2014
Last Verified: December 2014