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

November 13, 2023 updated by: Vanda Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Santa Monica Clinical Trials
        • Contact:
          • Dan Norman
          • Phone Number: 310-586-0843

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

  • 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tradipitant Dose A
"See Drug"
Drug: Tradipitant
Oral Capsule
Experimental: Tradipitant Dose B
"See Drug"
Drug: Tradipitant
Oral Capsule

What is the study measuring?

Primary Outcome Measures

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

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)

February 27, 2023

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3403

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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