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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/NCT04295538
Registration number
NCT04295538
Ethics application status
Date submitted
3/03/2020
Date registered
4/03/2020
Date last updated
10/06/2024
Titles & IDs
Public title
Safety And Efficacy Study Of Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper Extremity Motor Score (UEMS) In Adult Participants With Acute Traumatic Cervical Spinal Cord Injury (SCI)
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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 Traumatic Cervical Spinal Cord Injury
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Secondary ID [1]
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2019-003752-36
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Secondary ID [2]
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M16-077
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Universal Trial Number (UTN)
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Trial acronym
ELASCI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury (SCI)
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional(has expanded access)
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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
Solution for infusion; Intravenous (IV)
Treatment: Drugs: Placebo
Solution for infusion; Intravenous (IV)
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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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Upper Extremity Motor Score (UEMS)
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Assessment method [1]
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The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively.
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Timepoint [1]
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52 Weeks
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Secondary outcome [1]
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Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score
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Assessment method [1]
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The SCIM III self-care score addresses four areas of self-care management: feeding, grooming, bathing, and dressing. It has a total of 4 questions. Scores range from 0-20 where a score of 0 defines total dependence and 20 is indicative of complete independence.
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Timepoint [1]
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Week 0 through Week 52
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Secondary outcome [2]
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Change in Upper Extremity Motor Score (UEMS) From Baseline
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Assessment method [2]
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The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively.
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Timepoint [2]
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Week 0 through Week 52
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Eligibility
Key inclusion criteria
- Acute traumatic cervical spinal cord injury (SCI), neurological level of injury of C4,
C5, C6, or C7 with no damage to cord in thoracic (T2 and beyond) and lumbar regions
that, in the investigator's opinion, would significantly limit recovery.
- Maximum screening UEMS of 32.
- American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.
- Able to initiate study drug administration within 24 hours of injury.
- Participants with comorbid conditions that, in the investigator's opinion, are
clinically stable and not expected to meaningfully progress in the following 12
months, may be considered eligible to participate.
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Minimum age
18
Years
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Maximum age
75
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 complete spinal cord transection.
- Significant concomitant head injury with a clinically significant abnormality on a
head computed tomography (CT).
- One or more upper extremity muscle groups untestable (e.g., immobilized or restricted
by a cast) during the screening International Standards for Neurological
Classification of Spinal Cord Injury (ISNCSCI) examination.
- Known receipt of any other investigational product within 30 days or 5 half-lives of
the drug (whichever is longer) prior to the first dose of study drug or is currently
enrolled in another clinical study.
- 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.
- The cause of the acute SCI is one of the following: from gunshot or penetrating/stab
wound; non-traumatic SCI, results of seizure, or known attempted suicide.
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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 administering 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
6/09/2020
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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
17/04/2026
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Actual
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Sample size
Target
54
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital /ID# 216953 - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Georgia
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Illinois
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Kentucky
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Massachusetts
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North Carolina
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Canada
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Alberta
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Canada
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Canada
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Ontario
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Canada
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Quebec
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Israel
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Tel-Aviv
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Tokyo
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Japan
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Iizuka-shi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Incheon Gwang Yeogsi
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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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Spain
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Toledo
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Spain
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Valencia
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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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Ethics approval
Ethics application status
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Summary
Brief summary
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment
and sudden disability. Approximately 25,000 people experience cervical SCI in the United
States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is
safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute
traumatic cervical SCI.
Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is
a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes
the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded",
which means that neither trial participants nor the study doctors will know who will be given
which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms.
Each group receives a different treatment. There is a 1 in 3 chance that participants will be
assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled.
Approximately 54 participants will be enrolled in the study in approximately 49 sites
worldwide.
Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of
injury and every 4 weeks thereafter through Week 48 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 the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04295538
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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/NCT04295538
Download to PDF