Status:
TERMINATED
Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke
Lead Sponsor:
Diffusion Pharmaceuticals Inc
Collaborating Sponsors:
University of California, Los Angeles
University of Virginia
Conditions:
Stroke, Acute
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief 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 hospita...
Detailed Description
This is a multicenter, randomized, placebo-controlled, double-blind, parallel group trial of intravenous trans sodium crocetinate (TSC) initiated by emergency medical service (EMS) responders in the f...
Eligibility Criteria
Inclusion
- Age 40-85, inclusive
- Last known well time 15-120 minutes before anticipated study drug injection
- Suspected stroke identified by the LAPSS
- Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher
- No seizure
Exclusion
- Coma
- Rapidly improving neurologic deficit
- History of seizures or epilepsy
- Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
- SBP \< 90 or \> 220
- Major head trauma in the last 24 hours
- Recent stroke within 30 days
- Known to be pregnant or lactating
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03763929
Start Date
August 22 2019
End Date
October 19 2020
Last Update
June 18 2021
Active Locations (2)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of Virginia
Charlottesville, Virginia, United States, 22908