Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness

Phase 3

Recruiting

• Conditions: Motion Sickness
• Interventions: Drug: Tradipitant

• Registration Number: NCT06138613
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Detailed Description

This is an open label study to investigate the efficacy and safety of tradipitant in motion sickness affected male and female participants during events historically known to cause motion sickness.

Study Timeline

• Study Start: 2023-02-27
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• History of Motion Sickness
• Age 18-75

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tradipitant Dose A	Tradipitant	"See Drug"
Tradipitant Dose B	Tradipitant	"See Drug"

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).	through study completion, approximately 1 year	Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, and ECGs.

Trial Locations

Locations (1)

Santa Monica Clinical Trials; 🇺🇸 Santa Monica, California, United States