An interventional study of Rizatriptan and Placebo in Migraine, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-12-08.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
This group received placebo on visit 1 and Rizatriptan on visit 2.
Drug: Rizatriptan · Other: Placebo
These subjects received Rizatriptan on visit 1 and placebo on visit 2.
Drug: Rizatriptan · Other: Placebo
This group received placebo on visit 1 and Rizatriptan on visit 2.
Drug: Rizatriptan · Other: Placebo
This group received Rizatriptan on visit 1 and placebo on visit 2.
Drug: Rizatriptan · Other: Placebo
10 mg Rizatriptan in an unlabeled pill given once on one of two visits
Also known as: Maxalt
In an unlabeled pill given once on one of two visits.
Also known as: Sugar Pill
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)
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)
Subjects were recruited from the general public in Pittsburgh, PA from October 2006 until November 2008.
| Milestone | With Vertigo; Placebo-Rizatriptan | Without Vertigo; Placebo - Rizatriptan | With Vertigo; Rizatriptan - Placebo | Without Vertigo; Rizatriptan - Placebo |
|---|---|---|---|---|
| Started | 6 | 8 | 7 | 6 |
| Completed | 6 | 8 | 7 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | With Vertigo; Placebo-Rizatriptan | Without Vertigo; Placebo - Rizatriptan | With Vertigo; Rizatriptan - Placebo | Without Vertigo; Rizatriptan - Placebo |
|---|---|---|---|---|
| Started | 6 | 8 | 7 | 6 |
| Completed | 6 | 8 | 6 | 6 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Milestone | With Vertigo; Placebo-Rizatriptan | Without Vertigo; Placebo - Rizatriptan | With Vertigo; Rizatriptan - Placebo | Without Vertigo; Rizatriptan - Placebo |
|---|---|---|---|---|
| Started | 6 | 8 | 6 | 6 |
| Completed | 6 | 7 | 6 | 6 |
| Not completed | 0 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
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.
| units on a scale | Rizatriptan Visit | Placebo Visit |
|---|---|---|
| Change From Baseline in Motion Sickness to Post Vestibular Stimulus | 5.1 (2 to 10) | 9 (4.9 to 10.9) |
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.
| units on a scale | Rizatriptan Visit | Placebo Visit |
|---|---|---|
| Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus | 3 (0 to 5) | 2 (1 to 4) |
Collected over For the duration of the study visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Without Vertigo; Placebo | — | 0/14 (0%) | 1/14 (7.1%) |
| Without Vertigo; Rizatriptan | — | 0/14 (0%) | 0/14 (0%) |
| With Vertigo; Placebo | — | 0/12 (0%) | 0/12 (0%) |
| With Vertigo; Rizatriptan | — | 0/13 (0%) | 0/13 (0%) |
| Event | Without Vertigo; Placebo | Without Vertigo; Rizatriptan | With Vertigo; Placebo | With Vertigo; Rizatriptan |
|---|---|---|---|---|
| Increased Blood PressureGeneral disorders | 1/14 | 0/14 | 0/12 | 0/13 |
| NauseaGeneral disorders | 1/14 | 0/14 | 0/12 | 0/13 |
Twenty seven subjects completed screening tests and met study criteria. Twenty five of the 27 subjects enrolled completed both experimental study visits.
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 32 ± 8.0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 25 |
| Male | 2 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 27 |
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Studies of the drug tested here: Rizatriptan