Back to resultsMotion Serifos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Primary Purpose
Motion Sickness
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tradipitant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Motion Sickness
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
Sites / Locations
- Santa Monica Clinical TrialsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tradipitant
Placebo
Arm Description
Oral Capsule
Oral Capsule
Outcomes
Primary Outcome Measures
Prevention of vomiting measured by Vomiting Assessment (VA)
Prevention of vomiting measured by Vomiting Assessment (VA) score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05903924
Brief Title
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Official Title
Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (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
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tradipitant
Arm Type
Experimental
Arm Description
Oral Capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Tradipitant
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Prevention of vomiting measured by Vomiting Assessment (VA)
Description
Prevention of vomiting measured by Vomiting Assessment (VA) score
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
Daniel Norman, M.D.
Phone
310-586-0843
12. IPD Sharing Statement
Learn more about this trial
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
We'll reach out to this number within 24 hrs