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Elezanumab for Spinal Cord Injury (ELASCI Trial)
ELASCI Trial Summary
This trial is being done to find out if elezanumab is safe and to see if it improves motor function in people with acute cervical SCI.
ELASCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELASCI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ELASCI Trial Design
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Who is running the clinical trial?
Media Library
- I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have a spinal cord injury at the neck level without damage to my mid or lower back.I have a serious head injury with notable changes on a CT scan.You have severe impairment in your spinal cord function, as determined by a specific scale.My spinal cord injury is in the neck area without damage to my mid or lower back.My spinal injury is classified as complete or sensory incomplete.I have a spinal cord injury at the neck level without damage to my mid or lower back.You must have a maximum score of 32 on the screening UEMS.My spinal cord injury was caused by a gunshot, stabbing, seizure, or an attempted suicide.I cannot use one or more of my arm muscles during a specific nerve test.You have a complete spinal cord injury.I can start the study medication within a day of my injury.
- Group 1: Placebo
- Group 2: Elezanumab
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the precedence for this kind of drug testing?
"AbbVie first sponsored a clinical trial for Elezanumab in 2020. This initial study, which involved 54 participants, was immediately followed by Phase 2 drug approval. Now, there are 58 cities and 7 countries with active studies underway."
Are there any historical data points we can refer to with Elezanumab?
"The antibody drug elezanumab was first studied in 2020 at CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210. So far, there have been 18294 completed clinical trials. Right now, there are 2 ongoing studies with several of these trials based in Boston, Massachusetts."
Could I be a test subject for this research?
"This study is looking for 54 participants that have recently sustained a spinal cord injury, are between 18-75 years old, meet the American Spinal Injury Association Impairment Scale criteria, and have damage limited to the cervical region of their spinal cord."
What is the Elezanumab FDA approval process?
"While Phase 2 trials don't have data supporting efficacy, there is some information indicating that Elezanumab may be safe. Our analysts gave it a score of 2."
Is this clinical trial taking place in more than one hospital within the state?
"This study is currently enrolling patients at 29 locations. Some notable enrolment sites include Hopital du Sacre Coeur Montreal /ID# 215210 in Boston, Brigham and Women's Hospital /ID# 216342 in Sacramento, and UC Davis Health-Neurological Surgery /ID# 224892 in Portland."
How many people are signing up for this clinical trial?
"In order to move forward with this study, we need 54 individuals that meet the pre-specified eligibility requirements. Those interested can participate at Hopital du Sacre Coeur Montreal /ID# 215210 in Boston, Massachusetts or Brigham and Women's Hospital /ID# 216342 in Sacramento, California."
Is this clinical trial intended for a specific age demographic?
"Enrolment for this study is only possible for those aged 18-75. There are a total of 144 trials involving minors and 770 studies with elderly patients."
Can new participants join this research project at this time?
"Indeed, the latest information available on clinicaltrials.gov reveals that this trial is still searching for participants. The original posting date was September 6th 2020 and the page was updated as recently as August 2nd 2022."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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