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

Migraine Clinical Trial

Official title:

Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360282
• Other study ID #: 0602009
• Secondary ID: 31449
• Status: Completed
• Phase: N/A
• First received: August 2, 2006
• Last updated: December 4, 2014
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Motion Sickness

Intervention

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

Other:
• Placebo
In an unlabeled pill given once on one of two visits.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	Pre and Post Stimulus (6 minutes apart)	No