ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 184 studies in Gastroparesis with a site in United States — 35 open to participants now, 43 under way, 2 of them phase 3. Gastroparesis · United States.

Other kind
7 of 184
2 open now
Registered
121st of 184
by date

Among the 184 studies in Gastroparesis with a site in United States, this one is one of 7 of another kind, and was the 121st registered.

By phase

184 studies; the count open now beside each. This study's row is marked.

No phase68 · 14 open
Observational39 · 17 open
Phase 238 · 0 open
Phase 312 · 0 open
Phase 110 · 1 open
Other kindthis study7 · 2 open
Phase 46 · 0 open
Phase 1/22 · 0 open
Phase 2/32 · 1 open

By the year they started

First in 2002; this study’s year is marked.

Size and results

Median enrollment 36 across the 136 interventional studies, 108 across the 39 observational. Of the 124 that completed or were terminated, 63 (51%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 184 studies in Gastroparesis with a site in United States, or all of them as a file.
02

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
03

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
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

06

Where to request access

15 of 15 sites recruiting
  • Vanda Investigational Site
    Maitland, Florida 32751, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Tampa, Florida 33613, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Wauconda, Illinois 60084, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Wichita, Kansas 67214, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Louisville, Kentucky 40202, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Chevy Chase, Maryland 20815, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Boston, Massachusetts 02215, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Chesterfield, Missouri 63005, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Charlotte, North Carolina 28209, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Tulsa, Oklahoma 74104, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Philadelphia, Pennsylvania 19104, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Nashville, Tennessee 37211, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Houston, Texas 77084, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Plano, Texas 75024, United States
    Available
    • · Contact202-734-3400
  • Vanda Investigational Site
    Spokane, Washington 99202, United States
    Available
    • · Contact202-734-3400
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT04474990
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

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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