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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
Sponsor:
Collaborator:
Merck
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00360282
First received: August 2, 2006
Last updated: December 23, 2009
Last verified: December 2009
History of Changes
  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:

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:
    Drug: Rizatriptan
    10 mg Rizatriptan in an unlabeled pill given once on one of two visits
    Other Name: Maxalt
    Other: Placebo
    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 May 21, 2013