TerminatedPhase 2

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

Stopped: The study was stopped due to lack of meaningful enrollment due to the COVID-19 pandemic.

United States6 participantsStarted 2019-08-22

Plain-language 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.

Who can participate

Age range40 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Global Disability Level on the Modified Rankin Score (mRS)

Timeframe: 90 days

Trial details

NCT IDNCT03763929

SponsorDiffusion Pharmaceuticals Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-19

Results submitted2021-05-24

View on ClinicalTrials.gov More Stroke, Acute trials