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Clinical Trial 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.

Clinical Trial Description

This is a multicenter, randomized, placebo-controlled, double-blind, parallel group trial of intravenous trans sodium crocetinate (TSC) initiated by paramedics in the field within 2 hours of symptom onset in 160 subjects with acute stroke. The primary objectives of the study are to evaluate the efficacy and safety of field-initiated TSC in improving the long-term functional outcome of subjects with acute stroke. Subjects with acute stroke will be identified in the field by emergency medical service responders who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Paramedics will deliver the single, field, bolus dose of study agent, TSC at 0.25 mg/kg or matched placebo, followed after hospital arrival by standard of care (SOC). No additional study drug will be administered in the hospital. Follow-up assessments will be performed at Emergency Department (ED) arrival, 24 hours, 48 hours, Day 4, Day 30, and Day 90. The study will be performed at up to 30 receiving hospital sites. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03763929
Study type Interventional
Source Diffusion Pharmaceuticals Inc
Contact Anna Grace, RN
Phone 434-220-0718
Status Not yet recruiting
Phase Phase 2
Start date August 1, 2019
Completion date July 1, 2021

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