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| ID | Type | Description | Link |
|---|---|---|---|
| 31449 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Vertigo; Placebo - Rizatriptan | Other | This group received placebo on visit 1 and Rizatriptan on visit 2. |
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| With Vertigo; Rizatriptan - Placebo | Other | These subjects received Rizatriptan on visit 1 and placebo on visit 2. |
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| Without Vertigo; Placebo - Rizatriptan | Other | This group received placebo on visit 1 and Rizatriptan on visit 2. |
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| Without Vertigo; Rizatriptan-Placebo | Other | This group received Rizatriptan on visit 1 and placebo on visit 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rizatriptan | Drug | 10 mg Rizatriptan in an unlabeled pill given once on one of two visits |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M Furman, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20862509 | Result | 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. | |
| 37042545 | Derived | Webster 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. |
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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)
Subjects were recruited from the general public in Pittsburgh, PA from October 2006 until November 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | With Vertigo; Placebo-Rizatriptan | These participants suffered from migraines with associated dizziness/vertigo. They were given placebo on visit one and Rizatriptan on visit 2. |
| FG001 | Without Vertigo; Placebo - Rizatriptan | These participants suffered from migraines but did not have associated dizziness/vertigo. This group received placebo on visit 1 and Rizatriptan on visit 2. |
| FG002 | With Vertigo; Rizatriptan - Placebo | These participants suffered from migraine and had associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2. |
| FG003 | Without Vertigo; Rizatriptan - Placebo | These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout 1-3 Weeks |
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| Second Intervention |
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Twenty seven subjects completed screening tests and met study criteria. Twenty five of the 27 subjects enrolled completed both experimental study visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes participants (migraineurs) with and without vertigo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Pre and Post Stimulus (about 6 minutes apart) |
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For the duration of the study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Without Vertigo; Placebo | These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Blood Pressure | General disorders | Non-systematic Assessment | On first experimental visit - Subject had an increase in blood pressure within the 2 hour window between taking pill and the rotational trials. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph M. Furman, MD, PhD | University of Pittsburgh | (412) 647-2115 | furmanjm@upmc.edu |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C093622 | rizatriptan |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Placebo | Other | In an unlabeled pill given once on one of two visits. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo Visit | Participants were pre-treated with placebo prior to vestibular stimulation. |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Pre and Post Stimulus (6 minutes apart) |
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| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Without Vertigo; Rizatriptan | These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits. | 0 | 14 | 0 | 14 |
| EG002 | With Vertigo; Placebo | These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits. | 0 | 12 | 0 | 12 |
| EG003 | With Vertigo; Rizatriptan | These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits. | 0 | 13 | 0 | 13 |
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| Nausea | General disorders | Non-systematic Assessment | On experimental visit one, the subject reported feeling nausea after taking the drug. |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |