Trial Outcomes & Findings for Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness (NCT NCT04327661)
NCT ID: NCT04327661
Last Updated: 2024-12-11
Results Overview
Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
366 participants
Primary outcome timeframe
1 day
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
Tradipitant High Dose
Tradipitant: Oral Capsule
|
Tradipitant Low Dose
Tradipitant: Oral Capsule
|
Placebo
Placebo: Oral Capsule
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
123
|
122
|
|
Overall Study
COMPLETED
|
120
|
123
|
122
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tradipitant High Dose
Tradipitant: Oral Capsule
|
Tradipitant Low Dose
Tradipitant: Oral Capsule
|
Placebo
Placebo: Oral Capsule
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Population does not include withdrawn subjects
Baseline characteristics by cohort
| Measure |
Tradipitant High Dose
n=121 Participants
Tradipitant: Oral Capsule
|
Tradipitant Low Dose
n=123 Participants
Tradipitant: Oral Capsule
|
Placebo
n=122 Participants
Placebo: Oral Capsule
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 14.84 • n=121 Participants
|
49.6 years
STANDARD_DEVIATION 14.40 • n=123 Participants
|
48.6 years
STANDARD_DEVIATION 13.48 • n=122 Participants
|
48.6 years
STANDARD_DEVIATION 14.23 • n=366 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=121 Participants
|
82 Participants
n=123 Participants
|
75 Participants
n=122 Participants
|
244 Participants
n=366 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=121 Participants
|
41 Participants
n=123 Participants
|
47 Participants
n=122 Participants
|
122 Participants
n=366 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=121 Participants
|
12 Participants
n=123 Participants
|
14 Participants
n=122 Participants
|
40 Participants
n=366 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=121 Participants
|
102 Participants
n=123 Participants
|
105 Participants
n=122 Participants
|
306 Participants
n=366 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=121 Participants
|
9 Participants
n=123 Participants
|
3 Participants
n=122 Participants
|
20 Participants
n=366 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=121 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=122 Participants
|
3 Participants
n=366 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=121 Participants
|
9 Participants
n=123 Participants
|
11 Participants
n=122 Participants
|
27 Participants
n=366 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=121 Participants
|
5 Participants
n=123 Participants
|
5 Participants
n=122 Participants
|
20 Participants
n=366 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=366 Participants
|
|
Race/Ethnicity, Customized
White
|
103 Participants
n=121 Participants
|
105 Participants
n=123 Participants
|
102 Participants
n=122 Participants
|
310 Participants
n=366 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=121 Participants
|
3 Participants
n=123 Participants
|
2 Participants
n=122 Participants
|
5 Participants
n=366 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=121 Participants
|
123 participants
n=123 Participants
|
122 participants
n=122 Participants
|
366 participants
n=366 Participants
|
|
Body Mass Index (BMI)
|
26.785 kg/m^2
STANDARD_DEVIATION 4.6327 • n=120 Participants • Population does not include withdrawn subjects
|
27.299 kg/m^2
STANDARD_DEVIATION 4.9265 • n=123 Participants • Population does not include withdrawn subjects
|
28.037 kg/m^2
STANDARD_DEVIATION 5.1835 • n=122 Participants • Population does not include withdrawn subjects
|
27.377 kg/m^2
STANDARD_DEVIATION 4.9342 • n=365 Participants • Population does not include withdrawn subjects
|
PRIMARY outcome
Timeframe: 1 dayPrevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
Outcome measures
| Measure |
Tradipitant High Dose
n=120 Participants
Oral Capsule
|
Tradipitant Low Dose
n=123 Participants
Oral Capsule
|
Placebo
n=122 Participants
Oral Capsule
|
|---|---|---|---|
|
Prevention of Vomiting Measured by Vomiting Assessment (VA)
|
22 Participants
|
24 Participants
|
54 Participants
|
Adverse Events
Tradipitant High Dose
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Tradipitant Low Dose
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tradipitant High Dose
n=120 participants at risk
Tradipitant: Oral Capsule
|
Tradipitant Low Dose
n=123 participants at risk
Tradipitant: Oral Capsule
|
Placebo
n=122 participants at risk
Placebo: Oral Capsule
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
8.3%
10/120 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
5.7%
7/123 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
2.5%
3/122 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
|
Nervous system disorders
Somnolence
|
8.3%
10/120 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
6.5%
8/123 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
0.82%
1/122 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
|
General disorders
Fatigue
|
8.3%
10/120 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
4.1%
5/123 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
0.00%
0/122 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER