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

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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

Targeted Conditions

Study Overview

Start Date
October 19, 2022
Completion Date
February 1, 2025
Enrollment
80
Date Posted
October 19, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona 85251, United States

Marcus Neuroscience Institute
Boca Raton, Florida 33486, 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

The Ohio State University
Columbus, Ohio 43210, 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
W. Haven-Sylvan, Oregon 97225, United States

Jefferson Abington Hospital
Abington, Pennsylvania 19001, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion 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 middle cerebral artery.
Onset of AIS (last time subject seen well) to randomization is ≤16 hours.
Intended endovascular treatment with an approved endovascular device.

Exclusion Criteria:

Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
Poor/no collateral circulation. (e.g. collateral score of 0 or 1).
ASPECT score of 0-4.
Current AIS is being treated with IV thrombolytic therapy (eg, alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
Intent to use any endovascular thrombectomy device that is not 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 (eg, aortic dissection, carotid stent).
Subjects with end-stage kidney disease.
Subjects taking a chronic anticoagulant (eg, warfarin, apixaban).
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.
Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
Subject has previously received scp776 in another clinical trial.

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
This is a Phase 2 randomized, placebo-controlled, double-blind study that will be conducted in 2 parts: sequential dose escalation in Part A, followed by dose expansion in Part B.

In Part A, approximately 40 evaluable subjects will be assigned 1:1:2 overall to Cohort 1, Cohort 2 or placebo. Doses of scp776 will be tested sequentially in 2 cohorts, each in parallel with a volume-matched placebo randomized as 1:1 scp776:placebo within each cohort, to maintain the overall 1:1:2 ratio. Subjects will receive doses of either normal saline (placebo) or scp776, approximately 24 hours apart.
NCTid (if applicable)
NCT05585606