Terminated

Phase 2
Age: 40Years - 85Years
All Genders
ID03763929

Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Efficacy and Safety of Trans Sodium Crocetinate (TSC) Administered Onboard Emergency Vehicles for Treatment of Suspected Stroke: PHAST-TSC

Led by Diffusion Pharmaceuticals Inc · Updated on 2021-06-18

6

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Diffusion Pharmaceuticals Inc

Lead Sponsor

U

University of California, Los Angeles

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will assess the potential efficacy and safety of TSC as early treatment for both ischemic and hemorrhagic stroke when administered while subject is in ambulance being transported to hospital.

CONDITIONS

Official Title

Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Age 40-85, inclusive
  2. Last known well time 15-120 minutes before anticipated study drug injection
  3. Suspected stroke identified by the LAPSS
  4. Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher
  5. No seizure
Not Eligible

You will not qualify if you...

  1. Coma
  2. Rapidly improving neurologic deficit
  3. History of seizures or epilepsy
  4. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
  5. SBP < 90 or > 220
  6. Major head trauma in the last 24 hours
  7. Recent stroke within 30 days
  8. Known to be pregnant or lactating

Trial Site Locations

Total: 2 locations

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Status Unknown

2

University of Virginia

Charlottesville, Virginia, United States, 22908

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial