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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Joseph Furman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00360282
First received: August 2, 2006
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention
Migraine
Drug: Rizatriptan
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change From Baseline in Motion Sickness to Post Vestibular Stimulus [ Time Frame: Pre and Post Stimulus (about 6 minutes apart) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus [ Time Frame: Pre and Post Stimulus (6 minutes apart) ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: August 2006
Study Completion Date: March 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Maxalt
Other: Placebo
In an unlabeled pill given once on one of two visits.
Other Name: Sugar Pill
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 Name: Maxalt
Other: Placebo
In an unlabeled pill given once on one of two visits.
Other Name: Sugar Pill
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 Name: Maxalt
Other: Placebo
In an unlabeled pill given once on one of two visits.
Other Name: Sugar Pill
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 Name: Maxalt
Other: Placebo
In an unlabeled pill given once on one of two visits.
Other Name: Sugar Pill

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Joseph M Furman, MD, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: Joseph Furman, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00360282     History of Changes
Other Study ID Numbers: 0602009, 31449
Study First Received: August 2, 2006
Results First Received: November 7, 2012
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Migraine
Triptans
Motion Sickness

Additional relevant MeSH terms:
Migraine Disorders
Motion Sickness
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Signs and Symptoms
Rizatriptan
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on May 03, 2015