Clinical trial NCT00360282: Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Official title: Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Triptans
Motion Sickness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-08-04
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Motion Sickness to Post Vestibular Stimulus
timeFrame: Pre and Post Stimulus (about 6 minutes apart)
Secondary outcomes:
measure: Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus
timeFrame: Pre and Post Stimulus (6 minutes apart)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Joseph M Furman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Furman JM, Marcus DA, Balaban CD. Rizatriptan reduces vestibular-induced motion sickness in migraineurs. J Headache Pain. 2011 Feb;12(1):81-8. doi: 10.1007/s10194-010-0250-z. Epub 2010 Sep 23.