Trial Outcomes & Findings for Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness (NCT NCT05903924)

Last Updated: 2025-04-04

Results Overview

Prevention of vomiting measured by Vomiting Assessment (VA) score. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

316 participants

Primary outcome timeframe

1 day

Results posted on

2025-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Tradipitant High Dose Tradipitant: Oral Capsule	Tradipitant Low Dose Tradipitant: Oral Capsule	Placebo Placebo: Oral Capsule
Overall Study STARTED	106	104	106
Overall Study COMPLETED	105	104	106
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tradipitant High Dose Tradipitant: Oral Capsule	Tradipitant Low Dose Tradipitant: Oral Capsule	Placebo Placebo: Oral Capsule
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tradipitant High Dose n=106 Participants Tradipitant: Oral Capsule	Tradipitant Low Dose n=104 Participants Tradipitant: Oral Capsule	Placebo n=106 Participants Placebo: Oral Capsule	Total n=316 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 14.67 • n=5 Participants	47.3 years STANDARD_DEVIATION 14.31 • n=7 Participants	45.3 years STANDARD_DEVIATION 14.86 • n=5 Participants	46.3 years STANDARD_DEVIATION 14.59 • n=4 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	62 Participants n=7 Participants	60 Participants n=5 Participants	178 Participants n=4 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	42 Participants n=7 Participants	46 Participants n=5 Participants	138 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=5 Participants	84 Participants n=7 Participants	82 Participants n=5 Participants	257 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	15 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	80 Participants n=5 Participants	88 Participants n=7 Participants	78 Participants n=5 Participants	246 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · Multiple	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment United States	106 participants n=5 Participants	104 participants n=7 Participants	106 participants n=5 Participants	316 participants n=4 Participants
Body Mass Index (BMI)	27.453 kg/m^2 STANDARD_DEVIATION 5.0221 • n=5 Participants	26.989 kg/m^2 STANDARD_DEVIATION 4.0170 • n=7 Participants	26.811 kg/m^2 STANDARD_DEVIATION 4.3017 • n=5 Participants	27.085 kg/m^2 STANDARD_DEVIATION 4.4638 • n=4 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	Tradipitant High Dose n=106 Participants Tradipitant: Oral Capsule	Tradipitant Low Dose n=104 Participants Tradipitant: Oral Capsule	Placebo n=106 Participants Placebo: Oral Capsule
Prevention of Vomiting Measured by Vomiting Assessment (VA)	11 Participants	19 Participants	40 Participants

Adverse Events

Tradipitant High Dose

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Tradipitant Low Dose

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tradipitant High Dose n=106 participants at risk Tradipitant: Oral Capsule	Tradipitant Low Dose n=104 participants at risk Tradipitant: Oral Capsule	Placebo n=106 participants at risk Placebo: Oral Capsule
Nervous system disorders Headache	9.4% 10/106 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.	8.7% 9/104 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.	8.5% 9/106 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
Nervous system disorders Somnolence	8.5% 9/106 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.	5.8% 6/104 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.	7.5% 8/106 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
General disorders Fatigue	11.3% 12/106 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.	8.7% 9/104 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.	5.7% 6/106 • Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.

Additional Information

Vanda Pharmaceuticals

Phone: 2027343400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place