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

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

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

Available
Individual Patients
Gastroparesis
Diabetic Gastroparesis

Drug: Tradipitant

NK-1 Receptor antagonist

Eligibility Criteria

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;

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
United States
Locations

Vanda Investigational Site
Maitland 4163220, Florida 4155751, United States

Vanda Investigational Site
Tampa 4174757, Florida 4155751, United States

Vanda Investigational Site
Wauconda 4915725, Illinois 4896861, United States

Vanda Investigational Site
Wichita 4281730, Kansas 4273857, United States

Vanda Investigational Site
Louisville 4299276, Kentucky 6254925, United States

Vanda Investigational Site
Chevy Chase 4351335, Maryland 4361885, United States

Vanda Investigational Site
Boston 4930956, Massachusetts 6254926, United States

Vanda Investigational Site
Chesterfield 4381072, Missouri 4398678, United States

Vanda Investigational Site
Charlotte 4460243, North Carolina 4482348, United States

Vanda Investigational Site
Tulsa 4553433, Oklahoma 4544379, United States

Vanda Investigational Site
Philadelphia 4560349, Pennsylvania 6254927, United States

Vanda Investigational Site
Nashville 4644585, Tennessee 4662168, United States

Vanda Investigational Site
Houston 4699066, Texas 4736286, United States

Vanda Investigational Site
Plano 4719457, Texas 4736286, United States

Vanda Investigational Site
Spokane 5811696, Washington 5815135, United States

Contacts

Vanda Pharmaceuticals
2027343400
clinicaltrials@vandapharma.com

Vanda Pharmaceuticals
NCT Number
Keywords
gastroparesis
idiopathic
diabetic
tradipitant
nausea
vomiting
stomach
motility
functional
NK-1 antagonist
neurokinin 1 receptor
Substance P
Expanded Access
MeSH Terms
Gastroparesis
Nausea
Vomiting