Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness
Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06138613
Collaborator
(none)
300
1
2
17.1
17.6
Study Details
Study Description
Brief Summary
An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Motion Delos: An Open Label Study to Investigate the Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel
Actual Study Start Date
:
Feb 27, 2023
Anticipated Primary Completion Date
:
Jul 30, 2024
Anticipated Study Completion Date
:
Jul 30, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tradipitant Dose A "See Drug" |
Drug: Tradipitant
Oral Capsule
|
| Experimental: Tradipitant Dose B "See Drug" |
Drug: Tradipitant
Oral Capsule
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs). [through study completion, approximately 1 year]
Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, and ECGs.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Santa Monica Clinical Trials | Santa Monica | California | United States | 90404 |
Sponsors and Collaborators
- Vanda Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT06138613
Other Study ID Numbers:
- VP-VLY-686-3403
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: