Effect of Rizatriptan on Rotational Motion Sickness in Migraineurs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change From Baseline in Motion Sickness to Post Vestibular Stimulus
研究概览
简要总结
The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of motion sickness
- •Currently suffering from migraines with at least 2 episodes during the previous 12 months
- •Previous use and tolerance to triptans
排除标准
- •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
研究组 & 干预措施
With Vertigo; Placebo - Rizatriptan
This group received placebo on visit 1 and Rizatriptan on visit 2.
干预措施: Rizatriptan (Drug)
With Vertigo; Placebo - Rizatriptan
This group received placebo on visit 1 and Rizatriptan on visit 2.
干预措施: Placebo (Other)
With Vertigo; Rizatriptan - Placebo
These subjects received Rizatriptan on visit 1 and placebo on visit 2.
干预措施: Rizatriptan (Drug)
With Vertigo; Rizatriptan - Placebo
These subjects received Rizatriptan on visit 1 and placebo on visit 2.
干预措施: Placebo (Other)
Without Vertigo; Placebo - Rizatriptan
This group received placebo on visit 1 and Rizatriptan on visit 2.
干预措施: Rizatriptan (Drug)
Without Vertigo; Placebo - Rizatriptan
This group received placebo on visit 1 and Rizatriptan on visit 2.
干预措施: Placebo (Other)
Without Vertigo; Rizatriptan-Placebo
This group received Rizatriptan on visit 1 and placebo on visit 2.
干预措施: Rizatriptan (Drug)
Without Vertigo; Rizatriptan-Placebo
This group received Rizatriptan on visit 1 and placebo on visit 2.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Motion Sickness to Post Vestibular Stimulus
时间窗: 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.
次要结局
- Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus(Pre and Post Stimulus (6 minutes apart))
研究者
Joseph Furman
Professor
University of Pittsburgh