A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
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 80 subjects will be enrolled in 30 sites worldwide.

 Participants will receive 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 will 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.
Inclusion Criteria:

 -  Clinical diagnosis of acute ischemic stroke in anterior circulation, supported by
 acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent
 with the clinical diagnosis.

 -  Able to initiate study drug administration within 24 hours of last known normal.

 -  National Institute of Health Stroke Scale (NIHSS) total score of 7 to 21, inclusive.

 -  Participants or their legally authorized representative confirms that prior to index
 stroke, no significant impairment in participant's ability to perform activities of
 daily living without assistance.

 Exclusion Criteria:

 -  Evidence of severe stroke on imaging based on available acute imaging studies
 performed under the standard of care.

 -  The index acute ischemic stroke is intended to be treated with endovascular therapy.

 -  Evidence of seizure at the onset of index stroke.

 -  Evidence of acute myocardial infarction.

 -  Symptoms are considered likely to resolve within the subsequent few hours (e.g.,
 transient ischemic attack [TIA]).

 -  Known history prior to randomization of clinically significant medical conditions
 (other than current acute ischemic stroke) or any other reason, including any
 physical, psychological, or psychiatric condition that in the investigator's opinion
 would compromise the safety or interfere with the participant's participation in this
 study.

 -  Known medical history of repeated episodes of complex migraine. Participants with
 history of complex migraine, but with imaging conclusively demonstrating an acute
 ischemic stroke are still allowed.

 -  Female who is pregnant, breastfeeding, or considering becoming pregnant during the
 study or for within 39 weeks (5 half-lives) after the last dose of study drug.

 -  No known receipt of any investigational product within 30 days or 5 half-lives of the
 drug (whichever is longer) prior to the first dose of study drug. No current
 enrollment in another interventional clinical study, including pharmacologic and
 behavioral interventional studies.