PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury

Drug
General health
Online since 4 November 2021, updated 838 days ago

About this trial

This trial is enrolling individuals with acute (less than 48 hours) incomplete spinal cord injuries to test the safety and effect of a drug (Sovateltide) in addition to standard clinical and supportive care. Researchers want to see if Sovateltide (also known as PMZ-1620) can increase the development of new nerve cells and blood vessels after spinal cord damage, thus promoting repair and recovery in the brain and spinal cord. If selected for the trial, participants will be randomly assigned to one of two study groups: Half will receive injections of saline (placebo control group); the other half will be administered the experimental drug, Sovateltide. Both groups will be provided standard supportive care. The injections will be intravenous (into a vein) and will be performed within the first week of the study (on day 1, day 3, day 6). Follow-up assessments (walking tests, EMG, MRI and CT) will be done over a period of three months.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C5 - S5
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 48 hours
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C5-S5
    Additionally, participants must
    have a BMI of less than 35
    NOT be dependent on ventilator
    NOT also have head injury

    What’s involved

    Type

    Drug

    Details

    Three intravenous injections within the first week of the study Follow-up assessment over three months (including walking tests, EMG, MRI and CT)

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Sensory function

    Standing/walking/mobility

    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
    • 10 Jan 2019
    • Organisation
    • Pharmazz, Inc.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 10 Jan 2019
    • Organisation
    • Pharmazz, 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