Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Drug
Pain
Online since 19 March 2024, updated 119 days ago

About this trial

This trial is enrolling 50 individuals with recent spinal cord injury (less than 2 months) to test if giving of a drug, Pregabalin (Lyrica), early after injury can prevent development of central neuropathic pain (a neurological condition that can occur after an injury to the brain or spinal cord and have painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing). This affects how you feel pain - you may have pain at rest, be hypersensitive to painful stimuli or feel pain in response to normally non-painful stimuli). This condition often has severe effects and can be difficult to treat. Individuals will be included only if they have not yet developed pain. If included, two thirds of the participants will receive Pregabalin daily for 3 months. One third (the control group) will not receive the drug. Final testing for pain development will be performed after 1 year. If neuropathic pain is diagnosed, everyone will receive pregabalin regardless of which group a participant was initially assigned to. If the pain persists, the drug therapy may change according to the provider (usual care).

Included participants

Gender
All
Age
18 - 70 years
Injury level
C4 - S5
  • Severity (AIS)?
  • Time since injury
    ≤ 2 months
    Healthy volunteers
    No
    C4-S5
    Additionally, participants must
    have SCI below C3

    What’s involved

    Type

    Drug

    Details

    - Two thirds of the participants will receive the drug Lyrica (Pregabalin) for 3 months - One third (the control group) will not receive drug. - Final testing of pain will be performed after 1 year.

    Potential benefits

    Main benefits

    Pain

    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
    • 13 Jul 2021
    • Organisation
    • Loewenstein Hospital
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 13 Jul 2021
    • Organisation
    • Loewenstein Hospital

    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