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

Vanda Pharmaceuticals126 enrolled

Overview

Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

126

Conditions

Motion Sickness

Interventions

TradipitantDRUG

Oral capsule

PlaceboDRUG

Oral capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive); * Body Mass Index (BMI) of ≥18 and \<40 kg/m2; * History or symptoms consistent with motion sickness Exclusion Criteria: * Chronic nausea due to condition other than motion sickness; * A positive test for drugs of abuse at the screening or evaluation visits; * Clinically significant deviation from normal clinical laboratory results

Locations (1)

Vanda Investigational Site

Santa Monica, California, United States

Outcomes

Primary Outcomes

The Most Severe Motion Sickness Severity During Vehicle Travel

As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement

Time frame: 1 day

Percentage of Vomiting

Defined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6).

Time frame: 1 day

Data from ClinicalTrials.gov

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