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

Overview

About this study

The purpose of this study is to assess the effectiveness, safety, tolerability, and pharmacokinetics (PK) of elezanumab in subjects with acute ischemic stroke to potentially accelerate recovery and/or provide more complete recovery by decreasing neuronal damage and enhancing restoration of neuronal activity. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult male or female, between 30 and 90 years of age, inclusive.
  • 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 23 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 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.
  • 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.

Eligibility last updated 11/30/21.  Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

William Freeman, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cumara O'Carroll, M.D., M.P.H.

Open for enrollment

Contact information:

Cumara O'Carroll M.D., M.P.H.

(480) 301-8100

More information

Publications

Publications are currently not available
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CLS-20505706

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