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

NCT03763929 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-06-18

Study results available
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Summary

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

  • Stroke, Acute

Interventions

DRUG

Trans-Sodium Crocetinate

In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.

OTHER

Placebo

The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.

Sponsors & Collaborators

Principal Investigators

  • Andrew Southerland, MD · University of Virginia

  • Nerses Sanossian, MD · University of Southern California

  • Karen Johnston, MD · University of Virginia

  • Jeffrey Saver, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2020-10-19
Completion
2020-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763929 on ClinicalTrials.gov