Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
- Registration Number
- NCT03772340
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tradipitant Tradipitant - Placebo Placebo -
- Primary Outcome Measures
Name Time Method The Most Severe Motion Sickness Severity During Vehicle Travel 1 day As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
Percentage of Vomiting 1 day 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanda Investigational Site
🇺🇸Santa Monica, California, United States