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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Motion Sickness

Treatments: Drug: Placebo; Drug: Tradipitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03772340

VP-VLY-686-2401

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Tradipitant

Experimental group

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo