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

Primary Purpose

Motion Sickness

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tradipitant High Dose
Tradipitant Low Dose
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santa Monica Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tradipitant High Dose

Tradipitant Low Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduction in the incidence of vomiting as measured by the MSSS
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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2020
Last Updated
March 26, 2020
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04327661
Brief Title
Motion Syros: A Randomized Study Investigating the Efficacy of Tradipitant in Treating Motion Sickness
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
425 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tradipitant High Dose
Arm Type
Experimental
Arm Title
Tradipitant Low Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tradipitant High Dose
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Tradipitant Low Dose
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Reduction in the incidence of vomiting as measured by the MSSS
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals
Phone
2027343400
Email
clinicaltrials@vandapharma.com
Facility Information:
Facility Name
Santa Monica Clinical Trials
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Norman
Phone
310-586-0843

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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