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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772340
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Motion Sickness Drug: Tradipitant Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Motion Sickness

Arm Intervention/treatment
Experimental: Tradipitant Drug: Tradipitant
Oral capsule

Placebo Comparator: Placebo Drug: Placebo
Oral capsule




Primary Outcome Measures :
  1. Reduction in the incidence of vomiting [ Time Frame: 1 Day ]
    As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement

  2. Improvement in the cardinal symptoms of motion sickness [ Time Frame: 1 Day ]
    As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
  • Body Mass Index (BMI) of ≥18 and ≤30 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772340


Locations
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United States, California
Vanda Investigational Site
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03772340    
Other Study ID Numbers: VP-VLY-686-2401
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motion Sickness