NCT05903924

Brief Summary

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants 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
316

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 4, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

June 5, 2023

Results QC Date

March 18, 2025

Last Update Submit

March 18, 2025

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. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited.

    1 day

Study Arms (3)

Tradipitant High Dose

EXPERIMENTAL
Drug: Tradipitant

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Tradipitant Low Dose

EXPERIMENTAL
Drug: Tradipitant

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 (5)

Pacific Research Partners

San Diego, California, 94607, United States

Location

Lumos Clinical Research

San Jose, California, 95124, United States

Location

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

Beacon Clinical Research

Boston, Massachusetts, 02169, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
No
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

June 5, 2023

First Posted

June 15, 2023

Study Start

September 9, 2023

Primary Completion

April 6, 2024

Study Completion

April 24, 2024

Last Updated

April 4, 2025

Results First Posted

April 4, 2025

Record last verified: 2025-03

Locations

US(5)