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

• Status: Terminated
• Trial end date: 2020-10-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diffusion Pharmaceuticals Inc
• Collaborators: University of California, Los Angeles; University of Virginia
• Treatments: Trans-sodium crocetinate; Vitamin A

Criteria

Inclusion Criteria:

1. Age 40-85, inclusive

2. Last known well time 15-120 minutes before anticipated study drug injection

3. Suspected stroke identified by the LAPSS

4. Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher

5. No seizure

Exclusion Criteria:

1. Coma

2. Rapidly improving neurologic deficit

3. History of seizures or epilepsy

4. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations

5. SBP < 90 or > 220

6. Major head trauma in the last 24 hours

7. Recent stroke within 30 days

8. Known to be pregnant or lactating