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Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

Phase 3
Completed
Conditions
Motion Sickness
Interventions
Drug: Placebo
Registration Number
NCT04327661
Lead Sponsor
Vanda Pharmaceuticals
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
366
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Tradipitant Low DoseTradipitant-
PlaceboPlacebo-
Tradipitant High DoseTradipitant-
Primary Outcome Measures
NameTimeMethod
Prevention of Vomiting Measured by Vomiting Assessment (VA)1 day

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Gulfcoast Psychiatric Associates

🇺🇸

Fort Myers, Florida, United States

Pacific Research Network, LLC

🇺🇸

San Diego, California, United States

Santa Monica Clinical Trials

🇺🇸

Santa Monica, California, United States

Harmony Clinical Research

🇺🇸

North Miami Beach, Florida, United States

Avita Clinical Research

🇺🇸

Tampa, Florida, United States

Beacon Clinical Research

🇺🇸

Quincy, Massachusetts, United States

Manhattan Medical Research

🇺🇸

New York, New York, United States

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