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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT03763929

Run by

Diffusion Pharmaceuticals Inc

People needed

6

Starts

2019-08-22

Expected to finish

2020-10-19

Last updated by the study team

2021-06-18

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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