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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by University of Pittsburgh. Recruitment status was Active, not recruiting

First Received on August 2, 2006. Last Updated on December 23, 2009 History of Changes

Sponsor:	University of Pittsburgh
Collaborator:	Merck
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00360282

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: Rizatriptan Other: Placebo	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Dizziness and Vertigo Migraine Motion Sickness

Drug Information available for: Rizatriptan Rizatriptan Benzoate

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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

Estimated Enrollment:	25
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2010
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Maxalt

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

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.

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360282

Locations

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

Sponsors and Collaborators

University of Pittsburgh

Merck

Investigators

Principal Investigator:

Joseph M Furman, MD, PhD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Dr. Joseph Furman, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00360282 History of Changes
Other Study ID Numbers:	0602009, Merck31449
Study First Received:	August 2, 2006
Last Updated:	December 23, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Migraine
Vertigo
Motion Sickness

Additional relevant MeSH terms:

Motion Sickness
Migraine Disorders
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012