Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

Drug
Arm/hand function
Online since 5 November 2021, updated 925 days ago

About this trial

This trial is recruiting individuals with acute cervical (neck area) spinal cord injuries to test the safety and effect of an experimental drug (MT-3921). Earlier studies have shown that the drug may protect nerves, reduce inflammation and promote regeneration. Participants will be randomized to either receive the MT-3921 drug injected into a vein or a placebo (inactive) drug. Final testing (i.e., arm and hand function tests) will be performed 6 months after the start of the intervention.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C4 - C7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≤ 3 weeks
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C4-C7
    Additionally, participants must
    have a body mass index <40
    NOT have penetrating spinal cord injury (gunshot or knife wound)
    NOT have hereditary fructose intolerance

    What’s involved

    Type

    Drug

    Details

    The participant will be randomized (2:1) to either receive 1) the MT-3921 drug injected into a vein or 2) a placebo drug. Frequency and total number of injections is not provided. Further information needs to be acquired directly from the investigator.” Final testing (i.e., arm and hand function tests and activities of daily living)) will be performed 6 months after the start of the intervention.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Sensory function

    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
    • 27 Aug 2021
    • Organisation
    • Mitsubishi Tanabe Pharma America Inc.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 27 Aug 2021
    • Organisation
    • Mitsubishi Tanabe Pharma America Inc.

    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