Back to resultsDoes a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rizatriptan
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Migraine focused on measuring Migraine, Triptans, Motion Sickness
Eligibility 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
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
With Vertigo; Placebo - Rizatriptan
With Vertigo; Rizatriptan - Placebo
Without Vertigo; Placebo - Rizatriptan
Without Vertigo; Rizatriptan-Placebo
Arm Description
This group received placebo on visit 1 and Rizatriptan on visit 2.
These subjects received Rizatriptan on visit 1 and placebo on visit 2.
This group received placebo on visit 1 and Rizatriptan on visit 2.
This group received Rizatriptan on visit 1 and placebo on visit 2.
Outcomes
Primary Outcome Measures
Change From Baseline in Motion Sickness to Post Vestibular Stimulus
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
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.
Full Information
NCT ID
NCT00360282
First Posted
August 2, 2006
Last Updated
December 4, 2014
Sponsor
University of Pittsburgh
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00360282
Brief Title
Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Official Title
Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Triptans, Motion Sickness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With Vertigo; Placebo - Rizatriptan
Arm Type
Other
Arm Description
This group received placebo on visit 1 and Rizatriptan on visit 2.
Arm Title
With Vertigo; Rizatriptan - Placebo
Arm Type
Other
Arm Description
These subjects received Rizatriptan on visit 1 and placebo on visit 2.
Arm Title
Without Vertigo; Placebo - Rizatriptan
Arm Type
Other
Arm Description
This group received placebo on visit 1 and Rizatriptan on visit 2.
Arm Title
Without Vertigo; Rizatriptan-Placebo
Arm Type
Other
Arm Description
This group received Rizatriptan on visit 1 and placebo on visit 2.
Intervention Type
Drug
Intervention Name(s)
Rizatriptan
Other Intervention Name(s)
Maxalt
Intervention Description
10 mg Rizatriptan in an unlabeled pill given once on one of two visits
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
In an unlabeled pill given once on one of two visits.
Primary Outcome Measure Information:
Title
Change From Baseline in Motion Sickness to Post Vestibular Stimulus
Description
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.
Time Frame
Pre and Post Stimulus (about 6 minutes apart)
Secondary Outcome Measure Information:
Title
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus
Description
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.
Time Frame
Pre and Post Stimulus (6 minutes apart)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Furman, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20862509
Citation
Furman JM, Marcus DA, Balaban CD. Rizatriptan reduces vestibular-induced motion sickness in migraineurs. J Headache Pain. 2011 Feb;12(1):81-8. doi: 10.1007/s10194-010-0250-z. Epub 2010 Sep 23.
Results Reference
result
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Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
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