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

University of Pittsburgh

Status: Completed

Conditions: Migraine

Treatments: Drug: Rizatriptan; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00360282

31449 (Other Identifier)

0602009

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 4 patient groups

With Vertigo; Placebo - Rizatriptan

Other group

Description:

This group received placebo on visit 1 and Rizatriptan on visit 2.

Treatment:

Other: Placebo

Drug: Rizatriptan

With Vertigo; Rizatriptan - Placebo

Other group

Description:

These subjects received Rizatriptan on visit 1 and placebo on visit 2.

Treatment:

Other: Placebo

Drug: Rizatriptan

Without Vertigo; Placebo - Rizatriptan

Other group

Description:

This group received placebo on visit 1 and Rizatriptan on visit 2.

Treatment:

Other: Placebo

Drug: Rizatriptan

Without Vertigo; Rizatriptan-Placebo

Other group

Description:

This group received Rizatriptan on visit 1 and placebo on visit 2.

Treatment:

Other: Placebo

Drug: Rizatriptan