The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).
This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose with a single interim analysis. Because AIS (acute ischemic stroke) is a medical emergency, the trial is designed to enable the administration of standard-of-care treatments without delay in order to save the life of the person concerned, restore good health or alleviate suffering. Participants harboring an acute ischemic stroke who are selected for endovascular revascularization without intravenous or intra-arterial thrombolytic therapy will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of nerinetide or placebo. Outcomes of the main trial will be evaluated throughout a 90 day observation period. Participants will be followed at 1-Year for the analytic sub-trial for further outcome assessment by telemedicine or telephone interview conducted by individuals blinded to the outcome of the main trial. This sub-trial will be conducted to explore the independent functioning and quality of life at 1-Year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
850
Vehicle only
Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes
Number of Participants With Independent Functioning on the Modified Rankin Scale (mRS), as Defined by a Score of 0-2
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Time frame: 90 days
Mortality Rate, as Defined by Event Rate (Percent) for Mortality Over the 90-day Study Period.
The estimand of mortality rate was the adjusted unconditional population difference in the number of deaths observed divided by the number of participants observed over the 90-day study period (mortality proportions) between treatment conditions (nerinetide vs. placebo) in the target patient population at Day 90. Deaths occurring over the Day 90 period were considered as non-responses.
Time frame: 90 days
Number of Participants Exhibiting a Worsening of Their Index Stroke.
Worsening of stroke is defined as (A) progression, or hemorrhagic transformation of the index stroke, as documented by medical imaging that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a ≥4 point increase from lowest NIHSS during hospitalization or (B) results in death from the index stroke.
Time frame: 90 days
Number of Participants With Good Neurological Outcome, as Defined by a Score of 0-2 on the NIHSS at Day 90 Post Randomization.
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.
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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Providence Little Company of Mary Medical Center - Torrance
Torrance, California, United States
Swedish Medical Center
Englewood, Colorado, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
University of Miami, Jackson Memorial Hospital
Miami, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
NYU Langone Hospital Brooklyn
Brooklyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
...and 71 more locations
Time frame: 90 days