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

Motion Sickness Clinical Trial

Official title:

Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772340
• Other study ID #: VP-VLY-686-2401
• Status: Completed
• Phase: Phase 2
• Start date: December 20, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: December 2018
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 27, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);

• Body Mass Index (BMI) of =18 and =30 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

Related Conditions & MeSH terms

• Motion Sickness

Intervention

Drug:
• Tradipitant
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the incidence of vomiting	As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement	1 Day
Primary	Improvement in the cardinal symptoms of motion sickness	As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement	1 Day