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Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
This study has been completed.
Sponsor:
University of Pittsburgh
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
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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 Intervention Model: Crossover Assignment Masking: Double Blind (Participant, 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 Joseph Furman, 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) ]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) ]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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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 ( Other Identifier: Merck ) |
| Study First Received: | August 2, 2006 |
| Results First Received: | November 7, 2012 |
| Last Updated: | December 4, 2014 |
Keywords provided by Joseph Furman, University of Pittsburgh:
|
Migraine Triptans Motion Sickness |
Additional relevant MeSH terms:
|
Migraine Disorders Motion Sickness Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Signs and Symptoms Rizatriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 18, 2017