Motion Delos: An Open Label Safety and Efficacy of Tradip... | NCT06138613

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

NCT06138613

Sponsor

Vanda Pharmaceuticals

Status

Active, not recruiting

Last Update Posted

Apr 16, 2026Actual

Enrollment

705Actual

Phase

Phase 3

Conditions

Motion Sickness

Interventions

Tradipitant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2023Actual

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Mar 3, 2023

First Submission Date that Met QC Criteria

Nov 13, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

705Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tradipitant Dose A	Experimental	"See Drug"	Drug: Tradipitant
Tradipitant Dose B	Experimental	"See Drug"	Drug: Tradipitant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tradipitant	Drug	Oral Capsule	Tradipitant Dose A Tradipitant Dose B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Monica Clinical Trials		Santa Monica	California	90404	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009041	Motion Sickness

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided