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Completed

NCT Number: NCT03772340

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

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

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Key information

Conditions

Motion Sickness Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tradipitant

Drug

Oral capsule

Placebo

Drug

Oral capsule

Primary outcomes

  1. The Most Severe Motion Sickness Severity During Vehicle Travel

    Time frame: 1 day

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

  2. Percentage of Vomiting

    Time frame: 1 day

    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).

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2018
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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