NCT04474990

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

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

Conditions

• Gastroparesis
• Diabetic Gastroparesis

Interventions

Type	Name	Description
DRUG	Tradipitant	NK-1 Receptor antagonist

Timeline

• First posted: 2020-07-17
• Last updated: 2025-08-24

Locations

15 sites across 1 country: United States