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

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Drug: Rizatriptan; Other: Placebo

• Registration Number: NCT00360282
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-02
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-04
• Primary Completion: 2009-01
• Study Completion: 2010-03
• Results First Submitted: 2012-11-07
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-04
• Last Update Submitted: 2014-12-04
• Results First Posted: 2014-12-08
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Without Vertigo; Placebo - Rizatriptan	Placebo	This group received placebo on visit 1 and Rizatriptan on visit 2.
With Vertigo; Placebo - Rizatriptan	Placebo	This group received placebo on visit 1 and Rizatriptan on visit 2.
Without Vertigo; Rizatriptan-Placebo	Placebo	This group received Rizatriptan on visit 1 and placebo on visit 2.
With Vertigo; Rizatriptan - Placebo	Placebo	These subjects received Rizatriptan on visit 1 and placebo on visit 2.
With Vertigo; Placebo - Rizatriptan	Rizatriptan	This group received placebo on visit 1 and Rizatriptan on visit 2.
With Vertigo; Rizatriptan - Placebo	Rizatriptan	These subjects received Rizatriptan on visit 1 and placebo on visit 2.
Without Vertigo; Placebo - Rizatriptan	Rizatriptan	This group received placebo on visit 1 and Rizatriptan on visit 2.
Without Vertigo; Rizatriptan-Placebo	Rizatriptan	This group received Rizatriptan on visit 1 and placebo on visit 2.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Motion Sickness to Post Vestibular Stimulus	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States