Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
2 other identifiers
interventional
36
1 country
1
Brief Summary
The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
December 8, 2014
CompletedDecember 8, 2014
December 1, 2014
2.4 years
August 2, 2006
November 7, 2012
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Pre and Post Stimulus (about 6 minutes apart)
Secondary Outcomes (1)
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus
Pre and Post Stimulus (6 minutes apart)
Study Arms (4)
With Vertigo; Placebo - Rizatriptan
OTHERThis group received placebo on visit 1 and Rizatriptan on visit 2.
With Vertigo; Rizatriptan - Placebo
OTHERThese subjects received Rizatriptan on visit 1 and placebo on visit 2.
Without Vertigo; Placebo - Rizatriptan
OTHERThis group received placebo on visit 1 and Rizatriptan on visit 2.
Without Vertigo; Rizatriptan-Placebo
OTHERThis group received Rizatriptan on visit 1 and placebo on visit 2.
Interventions
10 mg Rizatriptan in an unlabeled pill given once on one of two visits
In an unlabeled pill given once on one of two visits.
Eligibility Criteria
You may qualify if:
- History of motion sickness
- Currently suffering from migraines with at least 2 episodes during the previous 12 months
- Previous use and tolerance to triptans
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
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.
PMID: 20862509RESULTWebster KE, Dor A, Galbraith K, Haj Kassem L, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ. Pharmacological interventions for acute attacks of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;4(4):CD015322. doi: 10.1002/14651858.CD015322.pub2.
PMID: 37042545DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joseph M. Furman, MD, PhD
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph M Furman, MD, PhD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
August 1, 2006
Primary Completion
January 1, 2009
Study Completion
March 1, 2010
Last Updated
December 8, 2014
Results First Posted
December 8, 2014
Record last verified: 2014-12