NCT06138613

Brief Summary

An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
705

participants targeted

Target at P75+ for phase_3

Timeline
20mo left

Started Feb 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2023Dec 2027

Study Start

First participant enrolled

February 27, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 16, 2026

Status Verified

November 1, 2025

Enrollment Period

4.6 years

First QC Date

March 3, 2023

Last Update Submit

April 15, 2026

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).

    Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, and ECGs.

    through study completion, approximately 1 year

Study Arms (2)

Tradipitant Dose A

EXPERIMENTAL

"See Drug"

Drug: Tradipitant

Tradipitant Dose B

EXPERIMENTAL

"See Drug"

Drug: Tradipitant

Interventions

TradipitantDRUG

Oral Capsule

Tradipitant Dose ATradipitant Dose B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of Motion Sickness
  • Age 18-75

You may not qualify if:

  • Nausea-inducing disorder other than motion sickness
  • BMI \> 40
  • History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

November 18, 2023

Study Start

February 27, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

April 16, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)