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

December 4, 2014 updated by: Joseph Furman, University of Pittsburgh

Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Joseph M Furman, MD, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria

August 2, 2006

First Posted (Estimate)

August 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0602009
  • 31449 (Other Identifier: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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