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NCT06138613 Clinical Trial

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

Motion Sickness Clinical Trial

Official title:
Motion Delos: An Open Label Study to Investigate the Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06138613
Other study ID # VP-VLY-686-3403
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 27, 2023
Est. completion date April 30, 2025

Study information
Verified date March 2024
Source Vanda Pharmaceuticals
Contact Vanda Pharmaceuticals
Phone 2027343400
Email clinicaltrials@vandapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tradipitant
Oral Capsule

Locations
Country Name City State
United States Santa Monica Clinical Trials Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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