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)

Drug
Arm/hand function
Online since 5 November 2021, updated 894 days ago

About this trial

This is a study enrolling individuals with new (less than 24 hours) cervical (neck area) spinal cord injuries to test the safety and effectiveness of an experimental drug called elezanumab. Elezanumab is a protein in the body that is able to neutralize a molecule that inhibits nerve regeneration after SCI, thus allowing nerve growth and possible functional recovery. The study includes two groups, one receiving elezanumab, the other receiving a placebo (an inactive drug used to compare the groups). This study is double-blinded, which means that neither trial participants nor the study doctors will know who will be given which study drug. If selected for the trial, participants will have a 2 in 3 chance to be in the group receiving the drug, or 1 in 3 chance to be in the group receiving a placebo. This study will compare the groups and measure any changes in arm and hand function.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C4 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≤ 24 hours
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C4-C7

    What’s involved

    Type

    Drug

    Details

    Injection of the antibody, into a vein, within 24 hours of the spinal cord injury Injection of the antibody, into a vein, every 4 weeks for a total of 13 doses (48 weeks) Medical assessments, blood tests, checking for side effects and completing questionnaires

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Sep 2020
    • Organisation
    • AbbVie
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Sep 2020
    • Organisation
    • AbbVie

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more