SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Available

CT.gov ID

NCT04474990

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Diabetic Gastroparesis	Drug: 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

Study Design

Study Type:

Expanded Access

Official Title:

VP-VLY-686-3303: SINGLE-PATIENT EXPANDED ACCESS PROTOCOL FOR TRADIPITANT IN A SINGLE PATIENT WITH GASTROPARESIS

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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;