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A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants affected by motion sickness during travel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant High Dose | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Tradipitant Low Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | Oral Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Vomiting Measured by Vomiting Assessment (VA) | Prevention of vomiting measured by Vomiting Assessment (VA) score. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Research Partners | San Diego | California | 94607 | United States | ||
| Lumos Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42150111 | Derived | Nguyen T, Willett KC, Daly LR, Junker J, Andreescu O, Dima L. Tradipitant: A Novel Neurokinin-1 Receptor Antagonist for Motion Sickness. Am J Ther. 2026 May 14. doi: 10.1097/MJT.0000000000002147. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant High Dose | Tradipitant: Oral Capsule |
| FG001 | Tradipitant Low Dose | Tradipitant: Oral Capsule |
| FG002 | Placebo | Placebo: Oral Capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant High Dose | Tradipitant: Oral Capsule |
| BG001 | Tradipitant Low Dose | Tradipitant: Oral Capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevention of Vomiting Measured by Vomiting Assessment (VA) | Prevention of vomiting measured by Vomiting Assessment (VA) score. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. | Posted | Count of Participants | Participants | 1 day |
|
Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tradipitant High Dose | Tradipitant: Oral Capsule | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 2027343400 | clinicaltrials@vandapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2023 | Mar 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Oral Capsule |
|
| San Jose |
| California |
| 95124 |
| United States |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | United States |
| Beacon Clinical Research | Boston | Massachusetts | 02169 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| BG002 |
| Placebo |
Placebo: Oral Capsule |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Placebo: Oral Capsule
|
|
| 106 |
| 0 |
| 106 |
| 29 |
| 106 |
| EG001 | Tradipitant Low Dose | Tradipitant: Oral Capsule | 0 | 104 | 0 | 104 | 24 | 104 |
| EG002 | Placebo | Placebo: Oral Capsule | 0 | 106 | 0 | 106 | 19 | 106 |
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
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