The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). This study consists of 2 cohorts, Cohort A and Cohort B. Cohort A (redasemtide or placebo) will enroll participants who are ineligible for systemic thrombolysis and/or mechanical recanalization therapy. Cohort B (redasemtide or placebo) will enroll participants who are eligible to receive or who have received systemic thrombolysis and/or mechanical recanalization therapy as standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
680
Lyophilized white powder reconstituted in 0.9% saline for injection
Lyophilized white powder reconstituted in 0.9% saline for injection
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Augusta University
Augusta, Georgia, United States
Mercyhealth Javon Bea Hospital- Riverside
Rockford, Illinois, United States
Community Hospital
Munster, Indiana, United States
Modified Rankin Scale (mRS) Score at Day 90
Time frame: Day 90
Number of Participants With mRS Score of 0 to 2
Time frame: Day 90
Number of Participants With Barthel Index (BI) Score ≥ 95
Time frame: Day 90
mRS Score at Day 30
Time frame: Day 30
mRS Score at Day 180
Time frame: Day 180
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1
Time frame: Days 1, 5, 30, 90, and 180
Change From Baseline in NIHSS Score
Time frame: Baseline, Days 1, 5, 30, 90, and 180
Number of Participants With BI Score ≥ 95
Time frame: Days 5, 30, and 180
Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score
Time frame: Day 5, Days 90 and 180
Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score
Time frame: Day 5, Days 90 and 180
Patient Global Impression of Change Scale (PGI-C) Score
Time frame: Days 5, 90, and 180
Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score
Time frame: Day 5, Days 90 and 180
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