Stroke is one of the leading causes death and major functional disability worldwide. Treatment options for acute stroke are limited with many patients having residual neurologic impairment. The purpose of this study is to evaluate the safety and efficacy of elezanumab and assess change in neurologic function in participants following an acute ischemic stroke. Elezanumab is an investigational drug being developed for the treatment of acute ischemic stroke. This 52-week study is "double-blinded', which means that neither the participants nor the study doctors will know who will be given elezanumab and who will be given placebo (does not contain treatment drug). Participants will be assigned to one of two groups, called treatment arms. Participants in one arm will receive elezanumab and participants in the other arm will receive placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 120 subjects will be enrolled in 45 sites worldwide. Participants will be randomized to elezanumab or placebo by intravenous (IV) infusion within 24 hours of "last known normal" (time when the participant was last known to be without signs and symptoms of the current stroke) and every 4 weeks thereafter for 48 weeks for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of elezanumab will be checked by medical assessments, blood tests, evaluation of side effects, and completion of questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
121
Intravenous (IV) infusion
Intravenous (IV) infusion
Mayo Clinic Arizona /ID# 214957
Phoenix, Arizona, United States
Long Beach Medical Center /ID# 217210
Long Beach, California, United States
Georgetown University Hospital /ID# 216481
Washington D.C., District of Columbia, United States
Duplicate_Mayo Clinic /ID# 217567
Jacksonville, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 215047
Chicago, Illinois, United States
Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve During the Treatment Period
The National Institutes of Health Stroke Scale (NIHSS) is a neurological examination used to quantitatively measure the severity of acute stroke by evaluating impact of cerebral infarction on level of consciousness, gaze, visual field, facial palsy, motor ability of arm and leg, limb ataxia, sensation, language, dysarthria, and extinction/inattention. Domains are scored on a scale of 0 to 2, 0 to 3, or 0 to 4, for a total range of 0 to 42 points with higher scores indicating impairment. The monthly-adjusted AUC of the NIHSS total score for each treatment group was derived using the trapezoidal method and contrasts from a Mixed Model with Repeated Measures (MMRM). Please refer to the formula for AUCi in the Statistical Analysis Plan (SAP) where i = treatment group (placebo, elezanumab) and j = visit during the Treatment Period {Day 1, Day 2-4, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52}.
Time frame: Day 1 through Week 52
Responder Status Based on Modified Rankin Scale (mRS)
The mRS is used to assess participant's disability and functional dependence. It is a 6-point scale ranging from 0 (no symptoms) to 5 (severe disability), with additional rating of 6 if the participant is deceased.
Time frame: Week 52
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Duplicate_University of Kentucky Chandler Medical Center /ID# 216394
Lexington, Kentucky, United States
University of Louisville Hospital /ID# 217569
Louisville, Kentucky, United States
Tufts Medical Center /ID# 215053
Boston, Massachusetts, United States
University of Mississippi Medical Center /ID# 217587
Jackson, Mississippi, United States
St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
Kansas City, Missouri, United States
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