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

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04474990
• Other study ID #: VP-VLY-686-3303
• Status: Available

Study information

• Verified date: September 2023
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals
• Phone: 2027343400
• Email: clinicaltrials[@]vandapharma.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• Tradipitant
NK-1 Receptor antagonist

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States,