Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury

Drug
General health
Online since 15 March 2025, updated 98 days ago

About this trial

This proof of concept trial is enrolling 28 participants with very acute, traumatic thoracic spinal cord injury to test the safety of eletriptan hydrobromide (TZ-161), a repurposed drug originally approved for the treatment of migraines. TZ-161 activates serotonin receptors in the brain and spinal cord, involved in regulation of nerve signals. If included, participants will be randomly assigned to receive either oral administration of the drug once daily for 6 days alongside standard care, or to receive standard care alone. Final testing of safety will be performed after 6 months.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T1 - T12
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 24 null
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T1-T12

    What’s involved

    Type

    Drug

    Details

    - Participants will be randomly assigned to receive either oral administration of eletriptan hydrobromide (TZ-161) once daily for 6 days, alongside standard care, or standard care alone. - Final testing of safety will be performed after 6 months.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    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 soon
    • Trial start date
    • 1 Jan 2025
    • Organisation
    • Technophage, SA
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jan 2025
    • Organisation
    • Technophage, SA

    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