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NCT04327661 Clinical Trial

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

Motion Sickness Clinical Trial

Official title:
Motion Syros: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04327661
Other study ID # VLY-686-3401
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 26, 2020
Est. completion date April 12, 2023

Study information
Verified date March 2024
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel

Recruitment information / eligibility
Status Completed
Enrollment 365
Est. completion date April 12, 2023
Est. primary completion date April 12, 2023
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
• Placebo
Oral Capsule

Locations
Country Name City State
United States Beacon Clinical Research Boston Massachusetts
United States Gulfcoast Psychiatric Associates Fort Myers Florida
United States Manhattan Medical Research New York New York
United States Harmony Clinical Research North Miami Beach Florida
United States Pacific Research Partners San Diego California
United States Santa Monica Clinical Trials Santa Monica California
United States Avita Clinical Research Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of vomiting measured by Vomiting Assessment (VA) Prevention of vomiting measured by Vomiting Assessment (VA) score. Prevention of vomiting measured by Vomiting Assessment (VA) score. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. 1 day
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