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

NCT ID: NCT04327661

Last Updated: 2024-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-04-12

Brief Summary

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A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel

Detailed Description

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Conditions

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Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tradipitant High Dose

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Oral Capsule

Tradipitant Low Dose

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Oral Capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Capsule

Interventions

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Tradipitant

Oral Capsule

Intervention Type DRUG

Placebo

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pacific Research Network, LLC

San Diego, California, United States

Site Status

Santa Monica Clinical Trials

Santa Monica, California, United States

Site Status

Gulfcoast Psychiatric Associates

Fort Myers, Florida, United States

Site Status

Harmony Clinical Research

North Miami Beach, Florida, United States

Site Status

Avita Clinical Research

Tampa, Florida, United States

Site Status

Beacon Clinical Research

Quincy, Massachusetts, United States

Site Status

Manhattan Medical Research

New York, New York, United States

Site Status

Countries

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United States

References

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Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025.

Reference Type DERIVED
PMID: 40103934 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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VP-VLY-686-3401

Identifier Type: -

Identifier Source: org_study_id