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

Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05903924
Enrollment
316
Registered
2023-06-15
Start date
2023-09-09
Completion date
2024-04-24
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motion Sickness

Brief summary

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants affected by motion sickness during travel

Interventions

DRUGTradipitant

Oral Capsule

DRUGPlacebo

Oral Capsule

Sponsors

Vanda Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* History of motion sickness * Age 18-75

Exclusion criteria

* Nausea-inducing disorder other than motion sickness * BMI\>40 * History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Design outcomes

Primary

MeasureTime frameDescription
Prevention of Vomiting Measured by Vomiting Assessment (VA)1 dayPrevention 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Tradipitant High Dose
Tradipitant: Oral Capsule
106
Tradipitant Low Dose
Tradipitant: Oral Capsule
104
Placebo
Placebo: Oral Capsule
106
Total316

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up100

Baseline characteristics

CharacteristicTradipitant High DoseTradipitant Low DosePlaceboTotal
Age, Continuous46.2 years
STANDARD_DEVIATION 14.67
47.3 years
STANDARD_DEVIATION 14.31
45.3 years
STANDARD_DEVIATION 14.86
46.3 years
STANDARD_DEVIATION 14.59
Body Mass Index (BMI)27.453 kg/m^2
STANDARD_DEVIATION 5.0221
26.989 kg/m^2
STANDARD_DEVIATION 4.017
26.811 kg/m^2
STANDARD_DEVIATION 4.3017
27.085 kg/m^2
STANDARD_DEVIATION 4.4638
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants16 Participants16 Participants43 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
91 Participants84 Participants82 Participants257 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants4 Participants8 Participants16 Participants
Race/Ethnicity, Customized
Race
American Indian or Alaskan Native
0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Race
Asian
15 Participants9 Participants12 Participants36 Participants
Race/Ethnicity, Customized
Race
Black or African American
5 Participants4 Participants6 Participants15 Participants
Race/Ethnicity, Customized
Race
Multiple
3 Participants2 Participants4 Participants9 Participants
Race/Ethnicity, Customized
Race
Native Hawaiian or Pacific Islander
2 Participants0 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Race
Other
1 Participants1 Participants5 Participants7 Participants
Race/Ethnicity, Customized
Race
White
80 Participants88 Participants78 Participants246 Participants
Region of Enrollment
United States
106 participants104 participants106 participants316 participants
Sex: Female, Male
Female
56 Participants62 Participants60 Participants178 Participants
Sex: Female, Male
Male
50 Participants42 Participants46 Participants138 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1060 / 1040 / 106
other
Total, other adverse events
29 / 10624 / 10419 / 106
serious
Total, serious adverse events
0 / 1060 / 1040 / 106

Outcome results

Primary

Prevention of Vomiting Measured by Vomiting Assessment (VA)

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.

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Tradipitant High DosePrevention of Vomiting Measured by Vomiting Assessment (VA)11 Participants
Tradipitant Low DosePrevention of Vomiting Measured by Vomiting Assessment (VA)19 Participants
PlaceboPrevention of Vomiting Measured by Vomiting Assessment (VA)40 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026