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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04309474
Registration number
NCT04309474
Ethics application status
Date submitted
13/03/2020
Date registered
16/03/2020
Date last updated
27/06/2023
Titles & IDs
Public title
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
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Secondary ID [1]
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2019-003753-29
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Secondary ID [2]
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M19-148
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Elezanumab
Treatment: Drugs - Placebo
Experimental: Elezanumab - Participants will receive elezanumab dose A
Placebo Comparator: Placebo - Participants will receive placebo for elezanumab
Treatment: Drugs: Elezanumab
Intravenous (IV) infusion
Treatment: Drugs: Placebo
Intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period
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Assessment method [1]
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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 -42 points with higher scores indicating impairment.
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Timepoint [1]
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Week 0 through Week 52
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Secondary outcome [1]
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Responder Status based on Modified Rankin Scale (mRS)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 0 through Week 52
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Eligibility
Key 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.
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Minimum age
30
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/02/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
121
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital /ID# 239083 - St Leonards
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Recruitment hospital [2]
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The Royal Melbourne Hospital /ID# 240178 - Parkville
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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United States of America
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California
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District of Columbia
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Florida
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Illinois
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Massachusetts
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Mississippi
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Missouri
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New York
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Ohio
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Texas
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Canada
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Ontario
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Japan
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Fukuoka
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Japan
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Kagoshima
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Japan
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Nagano
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Japan
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Yamaguchi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Busan
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Seoul
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Guipuzcoa
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Spain
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Vizcaya
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04309474
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04309474
Download to PDF