NCT03772340

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

Completed Phase 2 Results posted Last updated 9 May 2025

What this trial tests

Phase 2 trial testing Tradipitant in Motion Sickness in 126 participants. Completed in 27 June 2019.

Timeline

20 December 2018

Primary endpoint
6 June 2019

27 June 2019

Quick facts

Lead sponsor	Vanda Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	126
Start date	20 December 2018
Primary completion	6 June 2019
Estimated completion	27 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Tradipitant — full drug profile →
• Placebo

Conditions studied

• Motion Sickness — all drugs for Motion Sickness →

Sponsor

Vanda Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Motion Sickness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Most Severe Motion Sickness Severity During Vehicle Travel Primary · 1 day

As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement

Group	Value	95% CI
Tradipitant	3.4	± 0.238
Placebo	3.75	± 0.239

Percentage of Vomiting Primary · 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).

Group	Value	95% CI
Tradipitant	52
Placebo	38
Tradipitant	11
Placebo	25

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tradipitant

Serious: 0/63 (0%)

Deaths: 0/63

Placebo

Serious: 0/63 (0%)

Deaths: 0/63

Other adverse events (4 terms — click to expand)

Reaction	System	Tradipitant	Placebo
Motion Sickness	Ear and labyrinth disorders	—	—
Somnolence	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03772340 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study.
   Polymeropoulos VM, Czeisler MÉ, Gibson MM, Anderson AA, et al · · 2020 · cited 10× · PMID 33117260 · DOI 10.3389/fneur.2020.563373
2. Validation of the motion sickness severity scale: Secondary analysis of a randomized, double-blind, placebo-controlled study of a treatment for motion sickness.
   Czeisler MÉ, Pruski JM, Wang P, Wang J, et al · · 2023 · cited 9× · PMID 36602998 · DOI 10.1371/journal.pone.0280058