A Phase 2 interventional study of Tradipitant and Placebo in Motion Sickness, sponsored by Vanda Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Vanda Pharmaceuticals · Phase 2, Interventional, and Treatment
Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 126 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →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.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tradipitant
Drug: Placebo
Oral capsule
Oral capsule
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
Time frame: 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).
Time frame: 1 day
| Milestone | Tradipitant | Placebo |
|---|---|---|
| Started | 63 | 63 |
| Completed | 63 | 63 |
| Not completed | 0 | 0 |
As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
| units on a scale | Tradipitant | Placebo |
|---|---|---|
| The Most Severe Motion Sickness Severity During Vehicle Travel | 3.4 ± 0.238 | 3.75 ± 0.239 |
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).
| Participants | Tradipitant | Placebo |
|---|---|---|
| Vomiting No | 52 | 38 |
| Vomiting Yes | 11 | 25 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tradipitant | 0/63 (0%) | 0/63 (0%) | 39/63 (61.9%) |
| Placebo | 0/63 (0%) | 0/63 (0%) | 39/63 (61.9%) |
| Event | Tradipitant | Placebo |
|---|---|---|
| Motion SicknessEar and labyrinth disorders | 19/63 | 27/63 |
| SomnolenceNervous system disorders | 17/63 | 8/63 |
| HeadacheNervous system disorders | 8/63 | 5/63 |
| NauseaGastrointestinal disorders | 4/63 | 2/63 |
| Age, Continuous(years) | Tradipitant | Placebo | Total |
|---|---|---|---|
| Mean | 38.6 ± 11.44 | 39.7 ± 12.65 | 39.1 ± 12.02 |
| Sex: Female, Male(Participants) | Tradipitant | Placebo | Total |
|---|---|---|---|
| Female | 50 | 47 | 97 |
| Male | 13 | 16 | 29 |
| Ethnicity (NIH/OMB)(Participants) | Tradipitant | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 22 | 21 | 43 |
| Not Hispanic or Latino | 41 | 42 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Tradipitant | Placebo | Total |
|---|---|---|---|
| American Indian or Alaskan Native | 0 | 1 | 1 |
| Asian | 6 | 8 | 14 |
| Black or African American | 6 | 4 | 10 |
| Native Hawaiian or Pacific Islander | 2 | 0 | 2 |
| White | 44 | 49 | 93 |
| Other | 5 | 1 | 6 |
| Region of Enrollment(participants) | Tradipitant | Placebo | Total |
|---|---|---|---|
| United States | 63 | 63 | 126 |
| Baseline BMI(kg/m^2) | Tradipitant | Placebo | Total |
|---|---|---|---|
| Mean | 26.58 ± 5.03 | 27.87 ± 4.858 | 27.22 ± 4.967 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2018 to primary completion in Jun 2019, 5 months.
Results were first posted in May 2025, 5 years 11 months after primary completion.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tradipitant