Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
1 other identifier
expanded_access
N/A
1 country
15
Brief Summary
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 17, 2020
CompletedAugust 24, 2025
August 1, 2025
July 13, 2020
August 18, 2025
Conditions
Keywords
Interventions
NK-1 Receptor antagonist
Eligibility Criteria
You may qualify if:
- Identified subject who requested expanded access
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Patient does not qualify for or does not have access to other clinical trials with tradipitant;
You may not qualify if:
- Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
- A positive test for drugs of abuse at the screening or evaluation visits;
- Exposure to any investigational medication in the past 60 days other than tradipitant
- Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
- Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Vanda Investigational Site
Maitland, Florida, 32751, United States
Vanda Investigational Site
Tampa, Florida, 33613, United States
Vanda Investigational Site
Wauconda, Illinois, 60084, United States
Vanda Investigational Site
Wichita, Kansas, 67214, United States
Vanda Investigational Site
Louisville, Kentucky, 40202, United States
Vanda Investigational Site
Chevy Chase, Maryland, 20815, United States
Vanda Investigational Site
Boston, Massachusetts, 02215, United States
Vanda Investigational Site
Chesterfield, Missouri, 63005, United States
Vanda Investigational Site
Charlotte, North Carolina, 28209, United States
Vanda Investigational Site
Tulsa, Oklahoma, 74104, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Vanda Investigational Site
Nashville, Tennessee, 37211, United States
Vanda Investigational Site
Houston, Texas, 77084, United States
Vanda Investigational Site
Plano, Texas, 75024, United States
Vanda Investigational Site
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 17, 2020
Last Updated
August 24, 2025
Record last verified: 2025-08