Motion SicknessPhase 2NCT03772340

Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

A Phase 2 study testing Tradipitant in people with Motion Sickness, run by Vanda Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Motion Sickness
What is being tested?: Tradipitant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: 1 siteUnited States
Study dates: 20 Dec 2018to 27 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
Body Mass Index (BMI) of ≥18 and <40 kg/m2;
History or symptoms consistent with motion sickness

Who cannot join

Chronic nausea due to condition other than motion sickness;
A positive test for drugs of abuse at the screening or evaluation visits;
Clinically significant deviation from normal clinical laboratory results

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanda Investigational Site
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel

Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.

Conditions: Motion Sickness
Being tested: Tradipitant, Placebo
Medical subject headings: Motion Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TradipitantDrug
Oral capsule
PlaceboDrug
Oral capsule

Study groups in NCT03772340
Study group	Role	What they receive
Tradipitant	Experimental	Not described Receives: Drug: Tradipitant
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Most Severe Motion Sickness Severity During Vehicle Travel
As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
Measured: 1 day
Percentage of Vomiting
Defined 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).
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 201827 Jun 2019

First posted11 Dec 2018
Study start20 Dec 2018
Primary completion6 Jun 2019
Study completion27 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Motion SicknessStudies of the same condition, open and under way.
More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03772340
Sponsor's protocol ID: VP-VLY-686-2401
Status last verified: Apr 2024
First submitted: 28 Nov 2018
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Virtual Reality Sickness Questionnaire: Psychometrics in Stroke Patients
Motion Sickness
Not yet recruiting
Vagal Auricular Stimulation for Motion Sickness
Chronic Nausea
Recruiting
StableEyes With Active Neurofeedback
Vestibular Disorder, Vestibular Schwannoma
Not yet recruitingObservational study
Motion Sickness Severity and Sensorimotor Performance
Motion Sickness, Somatosensory Disorders
Not yet recruiting
OKT With Gaze and Postural Stabilization on Vertigo, MS and QOL in VBH
Vestibular Disorder

All Motion Sickness trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
ClinicalTrials.gov ID: NCT03772340
Acronym / sponsor ID: VP-VLY-686-2401
Conditions: Motion Sickness
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Dec 2018 (actual)
Primary completion: 6 Jun 2019 (actual)
Study completion: 27 Jun 2019 (actual)
First posted: 11 Dec 2018 (actual)
Results: Posted 9 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tradipitant	Experimental	Drug: Tradipitant
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
Body Mass Index (BMI) of ≥18 and <40 kg/m2;
History or symptoms consistent with motion sickness

Key exclusion criteria (3 listed)

Chronic nausea due to condition other than motion sickness;
A positive test for drugs of abuse at the screening or evaluation visits;
Clinically significant deviation from normal clinical laboratory results

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TradipitantOral capsule	Drug	Tradipitant
PlaceboOral capsule	Drug	Placebo

Primary outcome

The Most Severe Motion Sickness Severity During Vehicle Travel
Time frame: 1 day
As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
Percentage of Vomiting
Time frame: 1 day
Defined 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).

Results and safety

Results posted to the registry on 9 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tradipitant	63	63
Placebo	63	63

Primary outcome: The Most Severe Motion Sickness Severity During Vehicle Travel

Time frame: 1 day. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tradipitant n = 63	Placebo n = 63
Value	3.4 (0.238)	3.75 (0.239)

Primary outcome: Percentage of Vomiting

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Tradipitant n = 63	Placebo n = 63
Vomiting No	52	38
Vomiting Yes	11	25

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tradipitant	0 of 63 (0%)	39 of 63 (61.9%)	0 of 63
Placebo	0 of 63 (0%)	39 of 63 (61.9%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Motion Sickness

Enrolling by invitationObservational study
Virtual Reality Sickness Questionnaire: Psychometrics in Stroke Patients
Motion Sickness
Not yet recruiting
Vagal Auricular Stimulation for Motion Sickness
Chronic Nausea
Recruiting
StableEyes With Active Neurofeedback
Vestibular Disorder, Vestibular Schwannoma
Not yet recruitingObservational study
Motion Sickness Severity and Sensorimotor Performance
Motion Sickness, Somatosensory Disorders
Not yet recruiting
OKT With Gaze and Postural Stabilization on Vertigo, MS and QOL in VBH
Vestibular Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tradipitant in people with Motion Sickness, run by Vanda Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Most Severe Motion Sickness Severity During Vehicle Travel (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03772340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.