ACTIVE_NOT_RECRUITING

Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

Conditions

Acute Ischemic Stroke (AIS)Stroke, Acute Neuroprotectant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

Official Title

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

Quick Facts

Study Start:2022-10-19

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05585606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 18 years or older. * Body weight of less than 150 kg. * AIS intended for immediate endovascular treatment. * Disabling stroke defined as a baseline NIHSS ≥6 at the time of randomization. * Confirmed symptomatic intracranial occlusion, based on qualifying imaging, at one or more of the following locations: intracranial carotid artery and/or M1 or M2 middle cerebral artery. * Onset of AIS (last time subject seen well) to randomization is ≤24 hours. * Intended endovascular treatment with an approved endovascular device. * Pre-AIS (24 hours before stroke onset) independent functional status in activities of daily living with Modified Rankin Scale score of 0, 1, or 2. Subject must be living in their own home, apartment, or seniors' lodge where no nursing care is required. * Treating team and subject family are committed to full medical support for the subject. * Signed informed consent from subject or legally authorized representative, if required to enable inclusion by applicable national laws and regulations and the applicable independent review boards/ethics committee requirements for obtaining consent. Electronic consent is allowed in jurisdictions wherein this consent process is allowed. * Biologically female subjects must meet the following: 1. Subject must be surgically sterile or be at least 1 year postmenopausal, OR 2. Subjects of child-bearing potential must: 1. have a monogamous partner who is surgically sterile. 2. have a monogamous same sex partner. 3. be practicing abstinence or using an acceptable form of birth control while participating in the study through Day 90. Site personnel will provide instructions on what is an acceptable method. * If male, unless the subject has a same sex partner, be either sterile (surgically or biologically), commit to an acceptable double barrier method of birth control, or practice abstinence, until at least 30 days after study drug administration. Site personnel will provide instructions on what is an acceptable method.	* Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual. * Poor/no collateral circulation in the opinion of the investigator (e.g., collateral score of 0 or 1 if data available). * ASPECT score of 0-4. * Current AIS is being treated with IV thrombolytic therapy (e.g., alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours. * Intent to use any endovascular device that is not Food and Drug Administration (FDA)-approved. * Planned use of intra arterial thrombolytic therapy. * Known severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention. * Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention. * Known arterial condition that would prevent the mechanical device from achieving reperfusion (e.g., aortic dissection, carotid stent). * Subjects with end stage kidney disease. * Part A Cohort 1: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded. Chronic use of anti-platelet drugs is acceptable. * Part A Cohort 2: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. Chronic use of anti-platelet drugs is acceptable. * Part A Cohort 3 and Part B: With SRC approval, subjects in Part A Cohort 3 and Part B taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. * Known metastatic malignancy with poor prognosis. * Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator. Examples of excluded comorbid conditions include respiratory failure because of pneumonia, chronic diseases with significant disability, or non-ambulatory status. Contact medical monitor for consultation if necessary. * Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion. * Subject was a participant in either SCP CL 0001 or SCP CL 0002 and received scp776, or previously participated in SCP-CL-0003. * Subject is experiencing moderate or severe hypotension as defined by CTCAE criteria (i.e., symptomatic and requiring medical intervention with fluid resuscitation and/or vasopressors) or a confirmed systolic blood pressure less than 90 mmHg.

Inclusion Criteria

Exclusion Criteria

* Aged 18 years or older.
* Body weight of less than 150 kg.
* AIS intended for immediate endovascular treatment.
* Disabling stroke defined as a baseline NIHSS ≥6 at the time of randomization.
* Confirmed symptomatic intracranial occlusion, based on qualifying imaging, at one or more of the following locations: intracranial carotid artery and/or M1 or M2 middle cerebral artery.
* Onset of AIS (last time subject seen well) to randomization is ≤24 hours.
* Intended endovascular treatment with an approved endovascular device.
* Pre-AIS (24 hours before stroke onset) independent functional status in activities of daily living with Modified Rankin Scale score of 0, 1, or 2. Subject must be living in their own home, apartment, or seniors' lodge where no nursing care is required.
* Treating team and subject family are committed to full medical support for the subject.
* Signed informed consent from subject or legally authorized representative, if required to enable inclusion by applicable national laws and regulations and the applicable independent review boards/ethics committee requirements for obtaining consent. Electronic consent is allowed in jurisdictions wherein this consent process is allowed.
* Biologically female subjects must meet the following:
1. Subject must be surgically sterile or be at least 1 year postmenopausal, OR
2. Subjects of child-bearing potential must:
1. have a monogamous partner who is surgically sterile.
2. have a monogamous same sex partner.
3. be practicing abstinence or using an acceptable form of birth control while participating in the study through Day 90. Site personnel will provide instructions on what is an acceptable method.
* If male, unless the subject has a same sex partner, be either sterile (surgically or biologically), commit to an acceptable double barrier method of birth control, or practice abstinence, until at least 30 days after study drug administration. Site personnel will provide instructions on what is an acceptable method.

* Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
* Poor/no collateral circulation in the opinion of the investigator (e.g., collateral score of 0 or 1 if data available).
* ASPECT score of 0-4.
* Current AIS is being treated with IV thrombolytic therapy (e.g., alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
* Intent to use any endovascular device that is not Food and Drug Administration (FDA)-approved.
* Planned use of intra arterial thrombolytic therapy.
* Known severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
* Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
* Known arterial condition that would prevent the mechanical device from achieving reperfusion (e.g., aortic dissection, carotid stent).
* Subjects with end stage kidney disease.
* Part A Cohort 1: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded. Chronic use of anti-platelet drugs is acceptable.
* Part A Cohort 2: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. Chronic use of anti-platelet drugs is acceptable.
* Part A Cohort 3 and Part B: With SRC approval, subjects in Part A Cohort 3 and Part B taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization.
* Known metastatic malignancy with poor prognosis.
* Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator. Examples of excluded comorbid conditions include respiratory failure because of pneumonia, chronic diseases with significant disability, or non-ambulatory status. Contact medical monitor for consultation if necessary.
* Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
* Subject was a participant in either SCP CL 0001 or SCP CL 0002 and received scp776, or previously participated in SCP-CL-0003.
* Subject is experiencing moderate or severe hypotension as defined by CTCAE criteria (i.e., symptomatic and requiring medical intervention with fluid resuscitation and/or vasopressors) or a confirmed systolic blood pressure less than 90 mmHg.

Contacts and Locations

Study Locations (Sites)

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251

United States

Banner University Medical Center /Univ of Arizona

Tucson, Arizona, 85719

United States

Hartford Hospital

Hartford, Connecticut, 06106

United States

Marcus Neuroscience Institute

Boca Raton, Florida, 33486

United States

University of Miami - Jackson Memorial Hospital

Miami, Florida, 33136

United States

Augusta University Medical Center

Augusta, Georgia, 30912

United States

SSM Health DePaul Hospital

Bridgeton, Missouri, 63044

United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

UNM Hospital

Albuquerque, New Mexico, 87106

United States

Northshore University Hospital

Manhasset, New York, 11030

United States

Lennox Hill Hospital

New York, New York, 10075

United States

University of Cincinnati

Cincinnati, Ohio, 45219

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Mercy Health - St Vincent Medical Center

Toledo, Ohio, 43608

United States

Mercy Health - St Elizabeth Youngstown Hospital

Youngstown, Ohio, 44504

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Oregon Stroke Center at OHSU

Portland, Oregon, 97239

United States

Providence St. Vincent Medical Center

West Haven-Sylvan, Oregon, 97225

United States

Jefferson Abington Hospital

Abington, Pennsylvania, 19001

United States

Penn State Health - M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Houston Methodist Neurological Institute

Houston, Texas, 77030

United States

Medical College of Wisconsin and Froedtert Hospital

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Silver Creek Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-19

Study Completion Date2026-01

Study Record Updates

Study Start Date2022-10-19

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Stroke, Acute
Neuroprotectant

Additional Relevant MeSH Terms

Acute Ischemic Stroke (AIS)