A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke

Study Identifier
M19-148
CT.gov Identifier
NCT04309474
EudraCT Identifier
2019-003753-29
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
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Study Details

Medical Condition
  • Stroke
    • Study Drug
  • Elezanumab
  • Placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    30 - 90 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Clinical diagnosis of acute ischemic stroke, supported by acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis. * Able to randomize 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. * Evidence of acute seizure at the onset of index stroke without conclusive imaging of ischemic 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. * 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.

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Mayo Clinic Arizona /ID# 214957
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Long Beach Medical Center /ID# 217210
    Long Beach, California, United States, 90808-1731
    Status
    Not applicable
    Location
    Georgetown University Hospital /ID# 216481
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
    Location
    Duplicate_Mayo Clinic /ID# 217567
    Jacksonville, Florida, United States, 32224
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 215047
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
    Location
    Duplicate_University of Kentucky Chandler Medical Center /ID# 216394
    Lexington, Kentucky, United States, 40536
    Status
    Not applicable
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