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

August 18, 2025 updated by: Vanda Pharmaceuticals

VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

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

Study Overview

Status

Available

Conditions

Intervention / Treatment

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

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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