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

Diffusion Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Stroke, Acute

Treatments: Drug: Trans-Sodium Crocetinate; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03763929

100-501

Details and patient eligibility

About

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.

Full 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 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 and screened in the ambulance by (EMS) responders who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. The EMS responders will contact a Study Neurologist, who will enroll eligible stroke patients into the study. Effort will be made to obtain prospective informed consent in the ambulance when deemed to be feasible. If not feasible, subjects will be enrolled under regulations for exception from explicit informed consent (EFIC) in emergency research circumstances, after public disclosure and community consultation. Written informed consent to continue in the study is obtained from subjects or their legally authorized representatives as soon as possible after hospital arrival.

EMS responders 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 in Los Angeles County, CA, and central Virginia.

Enrollment: 6 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

Trans Sodium Crocetinate

Experimental group

Description:

Trans sodium crocetinate (TSC) will be administered intravenously as a bolus to subjects randomized to experimental drug. The bolus dose will consist of 0.25 mg/kg of TSC based on the estimated subject weight.

Treatment:

Drug: Trans-Sodium Crocetinate

Placebo

Placebo Comparator group

Description:

The placebo consists of commercially available sterile saline. Placebo will be administered intravenously as a bolus to subjects randomized to placebo. The volume of sterile saline will be based on the estimated subject weight.

Treatment:

Other: Placebo