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Motion Syros: A Randomized Study Investigating the Efficacy of Tradipitant in Treating 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327661
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Brief Summary:
A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of tradipitant in the treatment of motion sickness.

Condition or disease Intervention/treatment Phase
Motion Sickness Drug: Tradipitant High Dose Drug: Tradipitant Low Dose Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motion Syros: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Tradipitant in the Treatment of Motion Sickness
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Motion Sickness

Arm Intervention/treatment
Experimental: Tradipitant High Dose Drug: Tradipitant High Dose
Oral Capsule

Experimental: Tradipitant Low Dose Drug: Tradipitant Low Dose
Oral Capsule

Placebo Comparator: Placebo Drug: Placebo
Oral Capsule




Primary Outcome Measures :
  1. Reduction in the incidence of vomiting as measured by the MSSS [ Time Frame: 1 day ]
    Reduction in the incidence of vomiting as measured by the MSSS; Motion Sickness Severity Scale (MSSS) is a 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:

  • 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

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): NCT04327661


Contacts
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Contact: Vanda Pharmaceuticals 2027343400 clinicaltrials@vandapharma.com

Locations
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United States, California
Santa Monica Clinical Trials Recruiting
Santa Monica, California, United States, 90404
Contact: Dan Norman    310-586-0843      
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04327661    
Other Study ID Numbers: VLY-686-3401
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
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
Signs and Symptoms