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

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ClinicalTrials.gov Identifier: NCT03763929
Recruitment Status : Terminated (The study was stopped due to lack of meaningful enrollment due to the COVID-19 pandemic.)
First Posted : December 4, 2018
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
University of Virginia
Information provided by (Responsible Party):
Diffusion Pharmaceuticals Inc

Tracking Information
First Submitted Date  ICMJE December 3, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE August 22, 2019
Actual Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Global disability level on the Modified Rankin Score (mRS) [ Time Frame: 90 days ]
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
  1. = No significant disability despite symptoms; able to carry out all usual duties and activities
  2. = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. = Moderate disability; requiring some help, but able to walk without assistance
  4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  5. = Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. = Dead
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
Modified Rankin Scale (UW - mRS) [ Time Frame: 90 days ]
The primary efficacy objective is to test the hypothesis that treatment with TSC reduces the level of long-term disability of hyperacute stroke subjects. The study endpoint analysis to evaluate this hypothesis will be the difference in distribution of scores between TSC and placebo groups on the utility-weighted modified Rankin Scale (UW-mRS) measure of global disability, assessed 90-days post-stroke
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Functional Independence (mRS 0-2) [ Time Frame: 90 days ]
    No, minimal, or slight disability based on the modified Rankin score
  • Freedom from Disability (mRS 0-1) [ Time Frame: 90 days ]
    No or minimal disability based on the modified Rankin score
  • Activities of Daily Living (Barthel Index [BI]) [ Time Frame: 90 days ]
    The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten sub-items are: FEEDING (Range 0-10), BATHING (Range 0-5), GROOMING (Range 0-5), DRESSING (Range 0-10), BOWELS (Range 0-10), BLADDER (Range 0-10), TOILET USE (Range 0-10), TRANSFERS (Range 0-15), MOBILITY (Range 0-15), STAIRS (Range 0-10)
  • Neurologic Deficit (National Institutes of Health Stroke Score [NIHSS]) [ Time Frame: 90 days ]
    The National Institutes of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c. Level of Consciousness, 2. Best Gaze, 3. Visual, 4. Facial Palsy, 5a. Motor left arm, 5b. Motor right arm, 6a. Motor left leg, 6b. Motor right leg, 7. Limb Ataxia, 8. Sensory, 9. Best Language, 10. Dysarthria, 11. Extinction and Inattention
  • Qualify of Life (Stroke Impact Scale [SIS-16]) [ Time Frame: 90 days ]
    The Stroke Impact Scale - 16 (SIS-16) is a measure of stroke-specific quality of life. The scale assesses 16 questions on a scale from 1 = Could not do at all, to 5 = Not difficult at all. Total scores range from 15-80. Domains assessed are 1. Physical problems, 2. Daily activities, 3. Mobility at home and in the community, and 4. Affected hand use.
  • Quality of Life (AMC - Linear Disability Scale) [ Time Frame: 90 days ]
    The AMC-Linear Disability Scale (ALDS) is a calibrated generic item bank to measure the physical disability in patients. The ALDS is intended for use after assessing the modified Rankin Score, with different sets of questions for each Rankin score result. There are 15 questions in each level, which ask the patient "Can you..." questions about daily activities and mobility at home and in the community. For example, "Can you carry a bag of shopping upstairs?" The response options are Yes, Yes but it is difficult, No, and I don't know.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • Functional Independence (mRS 0-2) and improved quality of life [ Time Frame: 90 days ]
    Test the hypothesis that treatment with TSC improves the long-term outcome of hyperacute stroke subjects in achieving functional independence (mRS 0-2) at 90 days.
  • Freedom from Disability (mRS 0-1) [ Time Frame: 90 days ]
    Evaluate for signals of benefit of treatment with TSC upon freedom from disability (mRS 0-1) at 90 days.
  • Activities of Daily Living (Barthel Index [BI]) [ Time Frame: 90 days ]
    Evaluate for signals of benefit of treatment with TSC upon activities of daily living (Barthel Index [BI]) at 90 days
  • Neturologic Deficit (National Institutes of Health Stroke Score [NIHSS]) [ Time Frame: 90 days ]
    Evaluate for signals of benefit of treatment with TSC upon neurologic deficit (National Institutes of Health Stroke Score [NIHSS]) at 90 days.
  • Qualify of Life (Stroke Impact Scale [SIS-16]) [ Time Frame: 90 days ]
    Evaluate for signals of benefit of treatment with TSC upon quality of life (Stroke Impact Scale [SIS-16] at 90 days.
  • Quality of Life (AMC - Linear Disability Scale) [ Time Frame: 90 days ]
    Evaluate for signals of benefit of treatment with TSC upon quality of life (Stroke (AMC-Linear Disability Scale) at 90 days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, randomized, placebo-controlled, double-blind, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
TSC injections will be prepared and injected by unblinded personnel on each ambulance. All other study personnel will be blinded
Primary Purpose: Treatment
Condition  ICMJE Stroke, Acute
Intervention  ICMJE
  • 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 Name: TSC
  • Other: Placebo
    The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Trans-Sodium Crocetinate
  • Placebo Comparator: 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 14, 2020)
6
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
160
Actual Study Completion Date  ICMJE October 19, 2020
Actual Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03763929
Other Study ID Numbers  ICMJE 100-501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diffusion Pharmaceuticals Inc
Study Sponsor  ICMJE Diffusion Pharmaceuticals Inc
Collaborators  ICMJE
  • University of California, Los Angeles
  • University of Virginia
Investigators  ICMJE
Principal Investigator: Andrew Southerland, MD University of Virginia
Principal Investigator: Nerses Sanossian, MD University of Southern California
Study Chair: Karen Johnston, MD University of Virginia
Study Chair: Jeffrey Saver, MD University of California, Los Angeles
PRS Account Diffusion Pharmaceuticals Inc
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP