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

NCT ID: NCT00360282

Last Updated: 2014-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-03-31

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.

Conditions

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Migraine

Keywords

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Migraine Triptans Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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With Vertigo; Placebo - Rizatriptan

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

Group Type OTHER

Rizatriptan

Intervention Type DRUG

10 mg Rizatriptan in an unlabeled pill given once on one of two visits

Placebo

Intervention Type OTHER

In an unlabeled pill given once on one of two visits.

With Vertigo; Rizatriptan - Placebo

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

Group Type OTHER

Rizatriptan

Intervention Type DRUG

10 mg Rizatriptan in an unlabeled pill given once on one of two visits

Placebo

Intervention Type OTHER

In an unlabeled pill given once on one of two visits.

Without Vertigo; Placebo - Rizatriptan

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

Group Type OTHER

Rizatriptan

Intervention Type DRUG

10 mg Rizatriptan in an unlabeled pill given once on one of two visits

Placebo

Intervention Type OTHER

In an unlabeled pill given once on one of two visits.

Without Vertigo; Rizatriptan-Placebo

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

Group Type OTHER

Rizatriptan

Intervention Type DRUG

10 mg Rizatriptan in an unlabeled pill given once on one of two visits

Placebo

Intervention Type OTHER

In an unlabeled pill given once on one of two visits.

Interventions

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Rizatriptan

10 mg Rizatriptan in an unlabeled pill given once on one of two visits

Intervention Type DRUG

Placebo

In an unlabeled pill given once on one of two visits.

Intervention Type OTHER

Other Intervention Names

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Maxalt Sugar Pill

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Joseph Furman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph M Furman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20862509 (View on PubMed)

Webster KE, Dor A, Galbraith K, Haj Kassem L, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ. Pharmacological interventions for acute attacks of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;4(4):CD015322. doi: 10.1002/14651858.CD015322.pub2.

Reference Type DERIVED
PMID: 37042545 (View on PubMed)

Other Identifiers

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31449

Identifier Type: OTHER

Identifier Source: secondary_id

0602009

Identifier Type: -

Identifier Source: org_study_id