CompletedNCT05903924Updated Apr 4, 2025Results posted

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

A Phase 3 interventional study of Tradipitant and Placebo in Motion Sickness, sponsored by Vanda Pharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 316
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Conditions studied

Motion Sickness

Browse trials for

Motion Sickness 50

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's enrollment of 316 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.

Browse Vanda Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

History of motion sickness
Age 18-75

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 316 participants (actual)

Study arms

Experimental
Tradipitant High Dose
Drug: Tradipitant
Placebo comparator
Placebo
Drug: Placebo
Experimental
Tradipitant Low Dose
Drug: Tradipitant

Interventions

DrugTradipitant
Oral Capsule
DrugPlacebo
Oral Capsule

What researchers measure

Primary outcomes

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

Results

Posted Apr 4, 2025

Participant flow

Participant flow — Overall Study
Milestone	Tradipitant High Dose	Tradipitant Low Dose	Placebo
Started	106	104	106
Completed	105	104	106
Not completed	1	0	0
Withdrew: Lost to follow-up	1	0	0

Outcome measures

PrimaryPrevention 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
Reported as:: Count of participants · Participants

Prevention of Vomiting Measured by Vomiting Assessment (VA)
Participants	Tradipitant High Dose	Tradipitant Low Dose	Placebo
Prevention of Vomiting Measured by Vomiting Assessment (VA)	11	19	40

Adverse events

Collected over Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tradipitant High Dose	0/106 (0%)	0/106 (0%)	29/106 (27.4%)
Tradipitant Low Dose	0/104 (0%)	0/104 (0%)	24/104 (23.1%)
Placebo	0/106 (0%)	0/106 (0%)	19/106 (17.9%)

Most frequent other events

Most frequent other events
Event	Tradipitant High Dose	Tradipitant Low Dose	Placebo
FatigueGeneral disorders	12/106	9/104	6/106
HeadacheNervous system disorders	10/106	9/104	9/106
SomnolenceNervous system disorders	9/106	6/104	8/106

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Tradipitant High Dose	Tradipitant Low Dose	Placebo	Total
Mean	46.2 ± 14.67	47.3 ± 14.31	45.3 ± 14.86	46.3 ± 14.59

Sex: Female, Male
Sex: Female, Male(Participants)	Tradipitant High Dose	Tradipitant Low Dose	Placebo	Total
Female	56	62	60	178
Male	50	42	46	138

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Tradipitant High Dose	Tradipitant Low Dose	Placebo	Total
Hispanic or Latino	11	16	16	43
Not Hispanic or Latino	91	84	82	257
Unknown or Not Reported	4	4	8	16

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Tradipitant High Dose	Tradipitant Low Dose	Placebo	Total
Race — American Indian or Alaskan Native	0	0	1	1
Race — Asian	15	9	12	36
Race — Black or African American	5	4	6	15
Race — Native Hawaiian or Pacific Islander	2	0	0	2
Race — White	80	88	78	246
Race — Other	1	1	5	7
Race — Multiple	3	2	4	9

Region of Enrollment
Region of Enrollment(participants)	Tradipitant High Dose	Tradipitant Low Dose	Placebo	Total
United States	106	104	106	316

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	Tradipitant High Dose	Tradipitant Low Dose	Placebo	Total
Mean	27.453 ± 5.0221	26.989 ± 4.0170	26.811 ± 4.3017	27.085 ± 4.4638

Study locations

5 sites

Pacific Research Partners
San Diego, California 94607, United States
Lumos Clinical Research
San Jose, California 95124, United States
Santa Monica Clinical Trials
Santa Monica, California 90404, United States
Beacon Clinical Research
Boston, Massachusetts 02169, United States
Manhattan Medical Research
New York, New York 10016, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Nov 14, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Apr 2024, 6 months.

Results were first posted in Apr 2025, 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 5, 2023
First posted: Jun 15, 2023
StartActual: Sep 9, 2023
Primary completionActual: Apr 6, 2024
CompletionActual: Apr 24, 2024
Results first posted: Apr 4, 2025
Last update: Apr 4, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05903924
Lead sponsor: Vanda Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 15, 2023
Start date: Sep 9, 2023
Primary completion: Apr 6, 2024
Completion: Apr 24, 2024
Results posted: Apr 4, 2025
Last update: Apr 4, 2025

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tradipitant

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