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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Motion Sickness

Treatments: Drug: Tradipitant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04327661

VP-VLY-686-3401

Details and patient eligibility

About

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

Enrollment: 366 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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366 participants in 3 patient groups, including a placebo group

Tradipitant High Dose

Experimental group

Treatment:

Drug: Tradipitant

Tradipitant Low Dose

Experimental group

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo