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

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

Detailed Description
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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.

Official Title
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Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rizatriptan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: With Vertigo; Placebo - Rizatriptan<br>This group received placebo on visit 1 and Rizatriptan on visit 2. | Drug: Rizatriptan<br>* 10 mg Rizatriptan in an unlabeled pill given once on one of two visits<br>* Other names: Maxalt;Other: Placebo<br>* In an unlabeled pill given once on one of two visits.<br>* Other names: Sugar Pill;|
| Other: With Vertigo; Rizatriptan - Placebo<br>These subjects received Rizatriptan on visit 1 and placebo on visit 2. | Drug: Rizatriptan<br>* 10 mg Rizatriptan in an unlabeled pill given once on one of two visits<br>* Other names: Maxalt;Other: Placebo<br>* In an unlabeled pill given once on one of two visits.<br>* Other names: Sugar Pill;|
| Other: Without Vertigo; Placebo - Rizatriptan<br>This group received placebo on visit 1 and Rizatriptan on visit 2. | Drug: Rizatriptan<br>* 10 mg Rizatriptan in an unlabeled pill given once on one of two visits<br>* Other names: Maxalt;Other: Placebo<br>* In an unlabeled pill given once on one of two visits.<br>* Other names: Sugar Pill;|
| Other: Without Vertigo; Rizatriptan-Placebo<br>This group received Rizatriptan on visit 1 and placebo on visit 2. | Drug: Rizatriptan<br>* 10 mg Rizatriptan in an unlabeled pill given once on one of two visits<br>* Other names: Maxalt;Other: Placebo<br>* In an unlabeled pill given once on one of two visits.<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Motion Sickness to Post Vestibular Stimulus | 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. | Pre and Post Stimulus (about 6 minutes apart) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus | 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. | Pre and Post Stimulus (6 minutes apart) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Triptans, Motion Sickness