Stroke trial involving Los Angeles County investigators halted
A research study involving investigators in Los Angeles County, examining whether Trans Sodium Crocetinate (TSC) protects the threatened brain when administered to stroke victims by paramedics within the first two hours of stroke onset, has been closed due to, among other factors, challenges related to the COVID-19 pandemic.
“We are disappointed that the unexpected national health emergency prevented us from fully testing this potential brain-protecting drug in stroke patients at this time,” said Dr. Jeffrey Saver, study co-chair and professor of neurology at the David Geffen School of Medicine at UCLA. “The agent remains of great promise and we hope to be able to launch further studies once the pandemic has passed.”
Diffusion Pharmaceuticals Inc. of Charlottesville, Virginia, sponsored the now-closed trial of TSC as a new investigational treatment for acute stroke, which involved a consortium of Los Angeles County and Virginia hospitals and Emergency Medical Services provider agencies.
The trial, designated Pre-Hospital Administration of Stroke Therapy-Trans Sodium Crocetinate (PHAST-TSC), opened for patient enrollment generally in October 2019 and in January 2020 at UCLA with the assistance of two emergency services providers, Culver City Fire Department and Santa Monica Fire Department. PHAST-TSC was in the process of being opened at several other hospital sites in Los Angeles County when COVID-19 was declared a pandemic in March 2020. This prevented study start-up at the planned additional Los Angeles EMS Provider Agencies and hospitals.
The study had planned to enroll 160 patients, including 120 in Los Angeles County and 40 in Virginia. Prior to closure, 6 patients were enrolled, 4 in Los Angeles County and 2 in Virginia. Data from these patients is expected to be used to inform future studies by Diffusion.
Stroke is the fifth leading cause of death and a leading cause of disability in the United States. Each year, 795,000 Americans suffer a stroke. Available treatments for stroke are unsatisfactory, benefiting fewer than 1 in 20 patients.
The investigators thank the patients who participated in the study, and the dedicated paramedics, nurses, and doctors in Los Angeles County who performed the study.
The investigators welcome comments regarding the study from the public. These may be submitted to the PHAST-TSC Los Angeles Regional Coordinating Center at (310) 794-6379.