Motion SicknessPhase 3NCT04327661
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
A Phase 3 study testing Tradipitant in people with Motion Sickness, run by Vanda Pharmaceuticals at 7 sites in United States.
Trial summary
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel 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
- 366 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Nov 2021to 12 Apr 2023
- Phase
- Phase 3
- 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
- History of motion sickness
- Age 18-75
Who cannot join
- Nausea-inducing disorder other than motion sickness
- BMI>40
- History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Gulfcoast Psychiatric Associates
Fort Myers, Florida, 33912
Manhattan Medical Research
New York, New York, 10016
Harmony Clinical Research
North Miami Beach, Florida, 33162
Beacon Clinical Research
Quincy, Massachusetts, 02169
Pacific Research Network, LLC
San Diego, California, 92103
Santa Monica Clinical Trials
Santa Monica, California, 90025
Avita Clinical Research
Tampa, Florida, 33613
About this study
Official title: Motion Syros: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel
- 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 group | Role | What they receive |
|---|---|---|
| Tradipitant High Dose | Experimental | Not described Receives: Drug: Tradipitant |
| Tradipitant Low Dose | 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.
Prevention of Vomiting Measured by Vomiting Assessment (VA)
Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start15 Nov 2021
- Primary completion1 Apr 2023
- Study completion12 Apr 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327661
- Sponsor's protocol ID
- VP-VLY-686-3401
- Status last verified
- Nov 2024
- First submitted
- 26 Mar 2020
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen T, Willett KC, Daly LR, Junker J, Andreescu O, Dima L. Tradipitant: A Novel Neurokinin-1 Receptor Antagonist for Motion Sickness. Am J Ther. 2026 Jul-Aug 01;33(4):e324-e328. doi: 10.1097/MJT.0000000000002147. Epub 2026 May 14.
PubMed 42150111Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025.
PubMed 40103934
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Syros: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
- ClinicalTrials.gov ID
- NCT04327661
- Acronym / sponsor ID
- VP-VLY-686-3401
- Conditions
- Motion Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tradipitant High Dose | Experimental | Drug: Tradipitant |
| Tradipitant Low Dose | 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 (2 listed)
- History of motion sickness
- Age 18-75
Key exclusion criteria (3 listed)
- Nausea-inducing disorder other than motion sickness
- BMI>40
- History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
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 High Dose, Tradipitant Low Dose |
| PlaceboOral Capsule | Drug | Placebo |
Primary outcome
Prevention of Vomiting Measured by Vomiting Assessment (VA)
Time frame: 1 day
Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42150111Nguyen T, Willett KC, Daly LR, Junker J, Andreescu O, Dima L. Tradipitant: A Novel Neurokinin-1 Receptor Antagonist for Motion Sickness. Am J Ther. 2026 Jul-Aug 01;33(4):e324-e328. doi: 10.1097/MJT.0000000000002147. Epub 2026 May 14.
- Derived from this study: PubMed 40103934Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tradipitant in people with Motion Sickness, run by Vanda Pharmaceuticals at 7 sites 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 2 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Dec 2024). 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?
Prevention of Vomiting Measured by Vomiting Assessment (VA) (time frame: 1 day). 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 NCT04327661, which also lists 2 linked publications.
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 11 Dec 2024.