NCT03772340

Brief Summary

Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

November 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

May 9, 2025

Completed
Last Updated

May 9, 2025

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

November 28, 2018

Results QC Date

April 1, 2024

Last Update Submit

April 24, 2025

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (2)

  • The Most Severe Motion Sickness Severity During Vehicle Travel

    As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement

    1 day

  • Percentage of Vomiting

    Defined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6).

    1 day

Study Arms (2)

Tradipitant

EXPERIMENTAL
Drug: Tradipitant

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TradipitantDRUG

Oral capsule

Tradipitant
PlaceboDRUG

Oral capsule

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
  • Body Mass Index (BMI) of ≥18 and \<40 kg/m2;
  • History or symptoms consistent with motion sickness

You may not qualify if:

  • Chronic nausea due to condition other than motion sickness;
  • A positive test for drugs of abuse at the screening or evaluation visits;
  • Clinically significant deviation from normal clinical laboratory results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

Santa Monica, California, 90404, United States

Location

Related Links

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 2
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

November 28, 2018

First Posted

December 11, 2018

Study Start

December 20, 2018

Primary Completion

June 6, 2019

Study Completion

June 27, 2019

Last Updated

May 9, 2025

Results First Posted

May 9, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)