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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763929
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
University of Virginia
Information provided by (Responsible Party):
Diffusion Pharmaceuticals Inc

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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Drug: Trans-Sodium Crocetinate Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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
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
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Functional Independence (mRS 0-2) [ Time Frame: 90 days ]
    No, minimal, or slight disability based on the modified Rankin score

  2. Freedom from Disability (mRS 0-1) [ Time Frame: 90 days ]
    No or minimal disability based on the modified Rankin score

  3. 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)


  4. 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


  5. 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.

  6. 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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763929


Contacts
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Contact: Anna Grace, RN 434-220-0718 ext 116 agrace@diffusionpharma.com
Contact: John Gainer, PhD 434-220-0718 ext 105 jgainer@diffusionpharma.com

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Star Jorgensen, RN    310-794-6379    sjorgensen@mednet.ucla.edu   
Principal Investigator: Jeffrey L Saver, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sonya Gunter, MS    434-924-9664    sag7bf@hscmail.mcc.virginia.edu   
Principal Investigator: Andrew Southerland, MD         
Sponsors and Collaborators
Diffusion Pharmaceuticals Inc
University of California, Los Angeles
University of Virginia
Investigators
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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
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Responsible Party: Diffusion Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT03763929    
Other Study ID Numbers: 100-501
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases