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NCT05903924 Clinical Trial

Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness

Motion Sickness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05903924
Other study ID # VP-VLY-686-3404
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 10, 2023
Est. completion date April 2024

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date April 2024
Est. primary completion date April 2024
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 Manhattan Medical Research New York New York
United States Pacific Research Partners San Diego California
United States Lumos Clinical Research San Jose California
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 Prevention of vomiting measured by Vomiting Assessment (VA) 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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