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

NCT ID: NCT03763929

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2020-10-19

Brief 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.

Detailed 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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trans Sodium Crocetinate

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.

Group Type: EXPERIMENTAL

Trans-Sodium Crocetinate

Intervention Type: DRUG

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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

TSC

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Diffusion Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Southerland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Nerses Sanossian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Karen Johnston, MD

Role: STUDY_CHAIR

University of Virginia

Jeffrey Saver, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

Zachrison KS, Amati V, Schwamm LH, Yan Z, Nielsen V, Christie A, Reeves MJ, Sauser JP, Lomi A, Onnela JP. Influence of Hospital Characteristics on Hospital Transfer Destinations for Patients With Stroke. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008269. doi: 10.1161/CIRCOUTCOMES.121.008269. Epub 2022 Apr 4.

Reference Type: DERIVED

PMID: 35369714 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

100-501

Identifier Type: -

Identifier Source: org_study_id