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

Tracking Information

First Received Date ^ICMJE

August 2, 2006

Last Updated Date

October 10, 2008

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Motion Sickness Scores [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Motion Sickness Scores

Change History

Complete list of historical versions of study NCT00360282 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

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 to note abnormalities. There are 2 experimental visits in which migraine sufferers are given either the Rizatriptan or a fake pill and then are asked to rotate in a chair that is tilted. Motion sickness scores are taken throughout testing.

Study Phase

Phase 0

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: Rizatriptan
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2009

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Susan Strelinski	(412) 647-8088	strelinskisb@upmc.edu
Contact: Anita Lieb, MS, CCRC	(412) 647-8087	alieb@pitt.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00360282

Responsible Party

Dr. Joseph Furman, University of Pittsburgh

Study ID Numbers ^ICMJE

0602009, Merck31449

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Joseph M Furman, MD, PhD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP