Migraine
Conditions
Keywords
Migraine, Triptans, Motion Sickness
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.
Interventions
DRUGRizatriptan
10 mg Rizatriptan in an unlabeled pill given once on one of two visits
OTHERPlacebo
In an unlabeled pill given once on one of two visits.
Sponsors
Merck Sharp & Dohme LLC
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Motion Sickness to Post Vestibular Stimulus | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the general public in Pittsburgh, PA from October 2006 until November 2008.
Pre-assignment details
36 subjects recruited; 9 were not assigned to a group (3 did not not meet migraine inclusion criteria, 1 was excluded on vestibular screening results, 1 withdrew, 4 were lost to follow up)
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes participants (migraineurs) with and without vertigo | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Second Intervention | Adverse Event | 0 | 1 | 0 | 0 |
| Washout 1-3 Weeks | Lost to Follow-up | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 32 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 0 / 14 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 13 |
Outcome results
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.
Time frame: Pre and Post Stimulus (about 6 minutes apart)
Population: Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rizatriptan Visit | Change From Baseline in Motion Sickness to Post Vestibular Stimulus | 5.1 units on a scale |
| Placebo Visit | Change From Baseline in Motion Sickness to Post Vestibular Stimulus | 9 units on a scale |
p-value: 0.007Sign test
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.
Time frame: Pre and Post Stimulus (6 minutes apart)
Population: Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rizatriptan Visit | Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus | 3 units on a scale |
| Placebo Visit | Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus | 2 units on a scale |
p-value: 0.549Sign test