Riluzole in Spinal Cord Injury Study

Drug
General health
Online since 1 November 2021, updated 890 days ago

About this trial

This trial is recruiting individuals with acute cervical (neck area) spinal cord injuries to test an oral drug called Riluzole, a medication already approved for amyotrophic lateral sclerosis (ALS). Earlier studies suggest Riluzole is safe, may preserve spinal cord nerve tissue, and may improve behavioral outcomes. The trial will investigate whether the drug improves strength, recovery, and quality of life. Participants will receive the drug or placebo within 24 hours of injury for 14 days. Neither investigator nor participant will know who is in the treatment arm; this “masking” ensures unbiased procedures and objective outcomes.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C4 - C8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≤ 12 hours
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C4-C8
    Additionally, participants must
    NOT have had a previous spinal cord injury
    NOT have a penatrating injury, e.g. gunshot or stab

    What’s involved

    Type

    Drug

    Details

    Within 12 hours of the injury, the participant must be at one of the hospital study centers. The participant will be administered Riluzole or placebo orally twice-a-day for 14 days. Outcome assessments will be performed on day 1, 3, 7, Week 2, Month 3, 6 and 12 post-administration.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health

    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
    • Ended
    • Trial start date
    • 1 Oct 2013
    • Organisation
    • AOSpine North America Research Network
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Oct 2013
    • Organisation
    • AOSpine North America Research Network

    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