Trial Outcomes & Findings for Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines? (NCT NCT00360282)
NCT ID: NCT00360282
Last Updated: 2014-12-08
Results Overview
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.
COMPLETED
NA
36 participants
Pre and Post Stimulus (about 6 minutes apart)
2014-12-08
Participant Flow
Subjects were recruited from the general public in Pittsburgh, PA from October 2006 until November 2008.
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)
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Without Vertigo; Rizatriptan - Placebo
These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
6
|
8
|
7
|
6
|
|
First Intervention
COMPLETED
|
6
|
8
|
7
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 1-3 Weeks
STARTED
|
6
|
8
|
7
|
6
|
|
Washout 1-3 Weeks
COMPLETED
|
6
|
8
|
6
|
6
|
|
Washout 1-3 Weeks
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Second Intervention
STARTED
|
6
|
8
|
6
|
6
|
|
Second Intervention
COMPLETED
|
6
|
7
|
6
|
6
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
Without Vertigo; Rizatriptan - Placebo
These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
|
|---|---|---|---|---|
|
Washout 1-3 Weeks
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Second Intervention
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?
Baseline characteristics by cohort
| Measure |
All Study Participants
n=27 Participants
Includes participants (migraineurs) with and without vertigo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Rizatriptan Visit
n=15 Participants
Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
|
Placebo Visit
n=15 Participants
Participants were pre-treated with placebo prior to vestibular stimulation.
|
|---|---|---|
|
Change From Baseline in Motion Sickness to Post Vestibular Stimulus
|
5.1 units on a scale
Interval 2.0 to 10.0
|
9 units on a scale
Interval 4.9 to 10.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Rizatriptan Visit
n=15 Participants
Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
|
Placebo Visit
n=15 Participants
Participants were pre-treated with placebo prior to vestibular stimulation.
|
|---|---|---|
|
Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus
|
3 units on a scale
Interval 0.0 to 5.0
|
2 units on a scale
Interval 1.0 to 4.0
|
Adverse Events
Without Vertigo; Placebo
Without Vertigo; Rizatriptan
With Vertigo; Placebo
With Vertigo; Rizatriptan
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Without Vertigo; Placebo
n=14 participants at risk
These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits.
|
Without Vertigo; Rizatriptan
n=14 participants at risk
These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits.
|
With Vertigo; Placebo
n=12 participants at risk
These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits.
|
With Vertigo; Rizatriptan
n=13 participants at risk
These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits.
|
|---|---|---|---|---|
|
General disorders
Increased Blood Pressure
|
7.1%
1/14 • Number of events 1 • For the duration of the study visit.
|
0.00%
0/14 • For the duration of the study visit.
|
0.00%
0/12 • For the duration of the study visit.
|
0.00%
0/13 • For the duration of the study visit.
|
|
General disorders
Nausea
|
7.1%
1/14 • Number of events 1 • For the duration of the study visit.
|
0.00%
0/14 • For the duration of the study visit.
|
0.00%
0/12 • For the duration of the study visit.
|
0.00%
0/13 • For the duration of the study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place