NCT04327661

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

March 26, 2020

Results QC Date

October 29, 2024

Last Update Submit

November 19, 2024

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (1)

  • Prevention of Vomiting Measured by Vomiting Assessment (VA)

    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

Study Arms (3)

Tradipitant High Dose

EXPERIMENTAL
Drug: Tradipitant

Tradipitant Low Dose

EXPERIMENTAL
Drug: Tradipitant

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TradipitantDRUG

Oral Capsule

Tradipitant High DoseTradipitant Low Dose
PlaceboDRUG

Oral Capsule

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of motion sickness
  • Age 18-75

You may not qualify if:

  • Nausea-inducing disorder other than motion sickness
  • BMI\>40
  • History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pacific Research Network, LLC

San Diego, California, 92103, United States

Location

Santa Monica Clinical Trials

Santa Monica, California, 90025, United States

Location

Gulfcoast Psychiatric Associates

Fort Myers, Florida, 33912, United States

Location

Harmony Clinical Research

North Miami Beach, Florida, 33162, United States

Location

Avita Clinical Research

Tampa, Florida, 33613, United States

Location

Beacon Clinical Research

Quincy, Massachusetts, 02169, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Related Publications (1)

  • Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025.

    PMID: 40103934DERIVED

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Vanda Pharmaceuticals Inc.
Organization
Vanda Pharmaceuticals Inc.
clinicaltrials@vandapharma.com
2027343400

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 31, 2020

Study Start

November 15, 2021

Primary Completion

April 1, 2023

Study Completion

April 12, 2023

Last Updated

December 11, 2024

Results First Posted

December 11, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(7)