Trial Outcomes & Findings for Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness (NCT NCT03772340)
NCT ID: NCT03772340
Last Updated: 2025-05-09
Results Overview
As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
1 day
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Tradipitant
Tradipitant: Oral capsule
|
Placebo
Placebo: Oral capsule
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
63
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Baseline characteristics by cohort
| Measure |
Tradipitant
n=63 Participants
Tradipitant: Oral capsule
|
Placebo
n=63 Participants
Placebo: Oral capsule
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 12.65 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
63 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Baseline BMI
|
26.58 kg/m^2
STANDARD_DEVIATION 5.03 • n=5 Participants
|
27.87 kg/m^2
STANDARD_DEVIATION 4.858 • n=7 Participants
|
27.22 kg/m^2
STANDARD_DEVIATION 4.967 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayAs measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
Outcome measures
| Measure |
Tradipitant
n=63 Participants
Tradipitant: Oral capsule
|
Placebo
n=63 Participants
Placebo: Oral capsule
|
|---|---|---|
|
The Most Severe Motion Sickness Severity During Vehicle Travel
|
3.4 units on a scale
Standard Error 0.238
|
3.75 units on a scale
Standard Error 0.239
|
PRIMARY outcome
Timeframe: 1 dayDefined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6).
Outcome measures
| Measure |
Tradipitant
n=63 Participants
Tradipitant: Oral capsule
|
Placebo
n=63 Participants
Placebo: Oral capsule
|
|---|---|---|
|
Percentage of Vomiting
Vomiting No
|
52 Participants
|
38 Participants
|
|
Percentage of Vomiting
Vomiting Yes
|
11 Participants
|
25 Participants
|
Adverse Events
Tradipitant
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tradipitant
n=63 participants at risk
Tradipitant: Oral capsule
|
Placebo
n=63 participants at risk
Placebo: Oral capsule
|
|---|---|---|
|
Ear and labyrinth disorders
Motion Sickness
|
30.2%
19/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
42.9%
27/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
|
Nervous system disorders
Somnolence
|
27.0%
17/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
12.7%
8/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
|
Nervous system disorders
Headache
|
12.7%
8/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
7.9%
5/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
4/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
3.2%
2/63 • All Adverse Events (AEs) were collected from the time of the subject's informed consent signature until the end of the subject's study participation. AEs reported or learned up to 7 days after the subject's last study visit or a new SAE(s) up to 30 days after last study visit were recorded. AEs were monitored for approximately one month after randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER