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
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 60 evaluable subjects will be assigned 1:1:1:3 overall to Cohort 1, Cohort 2, Cohort 3, or placebo. Doses of scp776 will be tested sequentially in 3 cohorts, each in parallel with a volume-matched placebo randomized as 1:1 scp776:placebo within each cohort, to maintain the overall 1:1:1:3 ratio. Subjects will receive doses of either normal saline (placebo) or scp776, approximately 24 hours apart.• Cohort 1 dose regimen:- 1.9 mg/kg• Cohort 2 dose regimen:- 3.8 mg/kg• Cohort 3 dose regimen:- 4.8 mg/kg Upon completion of Part A, the study will proceed into Part B (dose expansion), in which approximately 40 subjects will be randomized 3:1 to the chosen scp776 therapeutic dose from Part A or volume-matched placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Volume Matched Placebo
Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes \- 1.9 mg/kg
Cohort 2 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes \- 3.8 mg/kg
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States
Total number of SAEs recorded prior to hospital discharge
Generalized linear models will be fit assuming a Poisson family with log link. The regression model will include a term for the duration of hospitalization. The regression models may also be adjusted for any or all of the following utilizing a stepwise approach: Time from LKW or stroke onset to reperfusion; Reperfusion Status (eTICI score from central read); Age; and, ASPECTS (raw score from central read).
Time frame: Baseline to Day 7 or at hospital discharge (whichever occurs first).
Proportion of subjects experiencing adverse events of special interest (AESIs)
Proportion of subjects experiencing adverse events of special interest (AESIs): * Hypoglycemia * Tachycardia * Bleeding events: * Symptomatic intracranial hemorrhage as per the central imaging review * Asymptomatic intracranial hemorrhage as per the central imaging review * Extracranial hemorrhage
Time frame: Baseline to Day 7 or at hospital discharge (whichever occurs first).
NIH Stroke Scale (NIHSS) Score at Day 7 / Discharge (whichever comes first)
NIH Stroke Scale score assessing neurological deficits and stroke severity. Scores range from 0 (no deficits) to 42 (severe deficits). NIHSS at discharge will be analyzed using Analysis of Covariance (ANCOVA). Terms to be included in the model are age, baseline NIHSS, ASPECTS, reperfusion status (TICI-based reperfusion grade), and treatment.
Time frame: Baseline to Day 7 or at hospital discharge (whichever occurs first).
NIH Stroke Scale (NIHSS) Score
NIH Stroke Scale (NIHSS) score assessing neurological deficits and stroke severity. Scores range from 0 (no deficits) to 42 (severe deficits).
Time frame: Daily from Days 1 through 7, Day 30, and Day 90.
Modified Rankin Scale (mRS) Score
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Cohort 3 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 4.8 mg/kg
A composite group encompassing all participants who received any dose level of the investigational drug under evaluation.
Banner University Medical Center /Univ of Arizona
Tucson, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Marcus Neuroscience Institute
Boca Raton, Florida, United States
University of Miami - Jackson Memorial Hospital
Miami, Florida, United States
Augusta University Medical Center
Augusta, Georgia, United States
SSM Health DePaul Hospital
Bridgeton, Missouri, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
UNM Hospital
Albuquerque, New Mexico, United States
Northshore University Hospital
Manhasset, New York, United States
...and 12 more locations
Assessment of disability after stroke using the Modified Rankin Scale, ranging from 0 (no disability) to 6 (death).
Time frame: Day 7 or discharge (whichever occurs first), Day 30, and Day 90.
Infarct Volume by Central Imaging Review
Infarct volume measured centrally via imaging (MRI or CT), evaluating ischemic lesion size.
Time frame: At 24 hours, and 72 - 96 hours or discharge (whichever occurs first).
All-cause Mortality
Incidence of death from any cause.
Time frame: By Day 30, and by Day 90.