Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

Available (expanded access)

Conditions studied: Gastroparesis, Diabetic Gastroparesis

In brief

Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Key facts

Study ID

NCT04474990

Run by

Vanda Pharmaceuticals

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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;

Where it is running

• Vanda Investigational Site — Maitland, Florida, United States
• Vanda Investigational Site — Tampa, Florida, United States
• Vanda Investigational Site — Wauconda, Illinois, United States
• Vanda Investigational Site — Wichita, Kansas, United States
• Vanda Investigational Site — Louisville, Kentucky, United States
• Vanda Investigational Site — Chevy Chase, Maryland, United States
• Vanda Investigational Site — Boston, Massachusetts, United States
• Vanda Investigational Site — Chesterfield, Missouri, United States
• Vanda Investigational Site — Charlotte, North Carolina, United States
• Vanda Investigational Site — Tulsa, Oklahoma, United States
• Vanda Investigational Site — Philadelphia, Pennsylvania, United States
• Vanda Investigational Site — Nashville, Tennessee, United States
• Vanda Investigational Site — Houston, Texas, United States
• Vanda Investigational Site — Plano, Texas, United States
• Vanda Investigational Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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