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NCT Number: NCT04309474

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 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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duplicate_Royal North Shore Hospital /ID# 239083, St Leonards, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

elezanumab

Drug

Intravenous (IV) infusion

Other names: ABT-555

Placebo

Drug

Intravenous (IV) infusion

Primary outcomes

  1. Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve During the Treatment Period

    Time frame: Day 1 through Week 52

    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}.

Secondary outcomes

  1. Responder Status Based on Modified Rankin Scale (mRS)

    Time frame: Week 52

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

Acronym: EAISE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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