- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138613
Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness
March 20, 2024 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
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)
500
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
- Name: Vanda Pharmaceuticals
- Phone Number: 2027343400
- Email: clinicaltrials@vandapharma.com
Study Locations
-
-
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"
|
Oral Capsule
|
Experimental: Tradipitant Dose B
"See Drug"
|
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
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)
April 30, 2025
Study Completion (Estimated)
April 30, 2025
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)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
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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