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

Stroke, Acute Clinical Trial

— PHAST-TSC  

Official title:

Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Efficacy and Safety of Trans Sodium Crocetinate (TSC) Administered Onboard Emergency Vehicles for Treatment of Suspected Stroke: PHAST-TSC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03763929
• Other study ID #: 100-501
• Status: Terminated
• Phase: Phase 2
• Start date: August 22, 2019
• Est. completion date: October 19, 2020

Study information

• Verified date: December 2020
• Source: Diffusion Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Drug:
• Trans-Sodium Crocetinate
In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.

Other:
• Placebo
The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Diffusion Pharmaceuticals Inc	University of California, Los Angeles, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Disability Level on the Modified Rankin Score (mRS)	Modified Rankin Scale (mRS) is a measure of global disability. Total scale range is 0-6, with lower values indicating better outcomes.; 0 = No symptoms at all; = No significant disability despite symptoms; able to carry out all usual duties and activities; = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; = Moderate disability; requiring some help, but able to walk without assistance; = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; = Dead	90 days