Motion SicknessPhase 3NCT05903924
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness
A Phase 3 study testing Tradipitant in people with Motion Sickness, run by Vanda Pharmaceuticals at 5 sites in United States.
Trial summary
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants 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
- 316 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Sep 2023to 24 Apr 2024
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beacon Clinical Research
Boston, Massachusetts, 02169
Manhattan Medical Research
New York, New York, 10016
Pacific Research Partners
San Diego, California, 94607
Lumos Clinical Research
San Jose, California, 95124
Santa Monica Clinical Trials
Santa Monica, California, 90404
About this study
Official title: Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants 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 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Tradipitant Low Dose | Experimental | Not described Receives: Drug: Tradipitant |
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. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have 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 posted15 Jun 2023
- Study start9 Sep 2023
- Primary completion6 Apr 2024
- Study completion24 Apr 2024
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 (1)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
- 316 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
- NCT05903924
- Sponsor's protocol ID
- VP-VLY-686-3404
- Status last verified
- Mar 2025
- First submitted
- 5 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 42150111
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel
- ClinicalTrials.gov ID
- NCT05903924
- Acronym / sponsor ID
- VP-VLY-686-3404
- Conditions
- Motion Sickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 6 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 4 Apr 2025
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 participants 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 |
| Placebo | Placebo comparator | Drug: Placebo |
| Tradipitant Low Dose | Experimental | Drug: Tradipitant |
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. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.
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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.
5 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 5 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 Apr 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?
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 NCT05903924, which also lists 1 linked publication.
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 4 Apr 2025.