Motion Sickness
Conditions
Brief summary
Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.
Interventions
DRUGTradipitant
Oral capsule
DRUGPlacebo
Oral capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tradipitant Tradipitant: Oral capsule | 63 |
| Placebo Placebo: Oral capsule | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | Tradipitant | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 11.44 | 39.7 years STANDARD_DEVIATION 12.65 | 39.1 years STANDARD_DEVIATION 12.02 |
| Baseline BMI | 26.58 kg/m^2 STANDARD_DEVIATION 5.03 | 27.87 kg/m^2 STANDARD_DEVIATION 4.858 | 27.22 kg/m^2 STANDARD_DEVIATION 4.967 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 21 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 42 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 49 Participants | 93 Participants |
| Region of Enrollment United States | 63 participants | 63 participants | 126 participants |
| Sex: Female, Male Female | 50 Participants | 47 Participants | 97 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 39 / 63 | 39 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tradipitant | Percentage of Vomiting | Vomiting Yes | 11 Participants |
| Tradipitant | Percentage of Vomiting | Vomiting No | 52 Participants |
| Placebo | Percentage of Vomiting | Vomiting No | 38 Participants |
| Placebo | Percentage of Vomiting | Vomiting Yes | 25 Participants |
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tradipitant | The Most Severe Motion Sickness Severity During Vehicle Travel | 3.4 units on a scale | Standard Error 0.238 |
| Placebo | The Most Severe Motion Sickness Severity During Vehicle Travel | 3.75 units on a scale | Standard Error 0.239 |