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AvailableNCT04474990Updated Aug 24, 2025

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

An expanded access record providing Tradipitant in Gastroparesis and Diabetic Gastroparesis, sponsored by Vanda Pharmaceuticals. Available at 15 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Vanda Pharmaceuticals · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant.

Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.

Primary Objective:

-To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Secondary Objectives:

  • To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
  • To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient
02

Conditions studied

  • Gastroparesis
  • Diabetic Gastroparesis

Keywords

  • gastroparesis
  • idiopathic
  • diabetic
  • tradipitant
  • nausea
  • vomiting
  • stomach
  • motility
  • functional
  • NK-1 antagonist
  • neurokinin 1 receptor
  • substance p
  • expanded access
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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;
04

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugTradipitant

    NK-1 Receptor antagonist

05

Where to request access

15 of 15 sites recruiting
  • Vanda Investigational Site
    Maitland, Florida 32751, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Tampa, Florida 33613, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Wauconda, Illinois 60084, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Wichita, Kansas 67214, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Louisville, Kentucky 40202, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Chevy Chase, Maryland 20815, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Boston, Massachusetts 02215, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Chesterfield, Missouri 63005, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Charlotte, North Carolina 28209, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Tulsa, Oklahoma 74104, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Philadelphia, Pennsylvania 19104, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Nashville, Tennessee 37211, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Houston, Texas 77084, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Plano, Texas 75024, United States
    • · Contact · 202-734-3400
    Available
  • Vanda Investigational Site
    Spokane, Washington 99202, United States
    • · Contact · 202-734-3400
    Available
06

Registry details

Key details

Study ID
NCT04474990
Lead sponsor
Vanda Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 17, 2020
Last update
Aug 24, 2025

Study contacts

Vanda Pharmaceuticals
Contact
clinicaltrials@vandapharma.com
2027343400
View the source record on ClinicalTrials.gov ↗

Requesting access

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