PHAST-TSC Trial

About

About the Trial

 

The Basics

purpose of this study

The purpose of this Phase 2 clinical trial is to study the efficacy and safety of field-initiated trans-sodium crocetinate (TSC) in improving the long-term functional outcome of subjects with acute stroke.

when and where

The study has begun enrollment as of August 28th 2019 in Charlottesville, Virginia. For the most up-to-date information please visit our study updates page.

Principal Investigator

Andrew Southerland, MD, MSc

Sponsor

Diffusion Pharmaceuticals, Inc.

Regulatory Information

The Food and Drug Administration (FDA) has approved an Investigational New Drug Application (IND) for the use of TSC and Exception From Informed Consent (EFIC) for PHAST-TSC.

Locally, the Institutional Review Board for Health Sciences Research at the University of Virginia oversees this study (IRB#21266).

How It Will Work

Learn more about how patients will be enrolled in the ambulance, how this study is regulated, and more below.

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Learn More about Elements of this Study

What is stroke?

A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts/ruptures.

When that happens, part of the brain cannot get the blood and oxygen it needs, so brain cells die.

Each year, 800,000 people experience a new or recurrent stroke; and it is the 5th leading cause of death in the U.S.

Learn more about stroke and how to recognize the signs here.

how has TSC been tested?

Trans Sodium Crocetinate (TSC) is a molecule developed by Diffusion Pharmaceuticals, Inc. that is like the natural compound crocetin. It is a drug that helps oxygen to move into tissues that don’t have enough oxygen like areas of the brain after stroke.

It has been tested in animal studies and was found to help decrease damage to tissue in the brain after stroke. In human studies, it has been tested in patients with peripheral arterial disease and brain tumor and shown to be safe and possibly beneficial.

The risks of TSC include:

  • skin or vein irritation at the site of injection

  • in human studies, a mild reversible yellow visual effect was reported by two people at doses 20 times higher than given in this study.

  • in animal studies, mild, yellow skin and urine discoloration and mild changes in blood tests were reported at doses 500 times higher than given in this study.

What is EFIC?

EFIC stands for Exception from Informed Consent.

EFIC is described in the Code of Regulations Title 21, Part 50, Section 24 (21 CFR 50.24). EFIC can only be used in studies when all of these are true:

  • the person’s life is at risk

  • the best treatment is not known

  • the study might help the person

  • it is not possible to get consent from the person because of his/her medical condition, or their family

The FDA and IRB-HSR at the University of Virginia have determined that this study meets the criteria for EFIC.

Investigators conducting research using EFIC must complete community consultation and public disclosure activities to inform, discuss, and solicit opinions from the community in which the study will take place