Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke (PHAST-TSC)
Primary Purpose
Stroke, Acute
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trans-Sodium Crocetinate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
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
Sites / Locations
- University of California, Los Angeles
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Trans Sodium Crocetinate
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03763929
First Posted
December 3, 2018
Last Updated
May 24, 2021
Sponsor
Diffusion Pharmaceuticals Inc
Collaborators
University of California, Los Angeles, University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT03763929
Brief Title
Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to lack of meaningful enrollment due to the COVID-19 pandemic.
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
October 19, 2020 (Actual)
Study Completion Date
October 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diffusion Pharmaceuticals Inc
Collaborators
University of California, Los Angeles, University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized, placebo-controlled, double-blind, parallel group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
TSC injections will be prepared and injected by unblinded personnel on each ambulance. All other study personnel will be blinded
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans Sodium Crocetinate
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Trans-Sodium Crocetinate
Other Intervention Name(s)
TSC
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Primary Outcome Measure Information:
Title
Global Disability Level on the Modified Rankin Score (mRS)
Description
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
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Southerland, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nerses Sanossian, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Johnston, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeffrey Saver, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35369714
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke
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