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

Status Available

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

• NCT number: NCT04474990
• Study type: Expanded Access
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals
• Phone: 2027343400
• Email: clinicaltrials@vandapharma.com
• Status: Available