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Motion Syros: A Randomized Study Investigating the Efficacy of Tradipitant in Treating Motion Sickness

Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04327661
Collaborator
(none)
425
Enrollment
1
Location
3
Arms
6.2
Anticipated Duration (Months)
68.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Tradipitant High Dose
  • Drug: Tradipitant Low Dose
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 26, 2020
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reduction in the incidence of vomiting as measured by the MSSS [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Monica Clinical Trials Santa Monica California United States 90404

Sponsors and Collaborators

  • Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04327661
Other Study ID Numbers:
  • VLY-686-3401
First Posted:
Mar 31, 2020
Last Update Posted:
Mar 31, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Motion Sickness

Study Results

No Results Posted as of Mar 31, 2020