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

November 19, 2024 updated by: Vanda Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Pacific Research Network, LLC
      • Santa Monica, California, United States, 90025
        • Santa Monica Clinical Trials
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Psychiatric Associates
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research
      • Tampa, Florida, United States, 33613
        • Avita Clinical Research
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research
    • New York
      • New York, New York, United States, 10016
        • Manhattan Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral Capsule
Experimental: Tradipitant High Dose
Drug: Tradipitant
Oral Capsule
Experimental: Tradipitant Low Dose
Drug: Tradipitant
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of Vomiting Measured by Vomiting Assessment (VA)
Time Frame: 1 day
Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 12, 2023

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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