Effects of 5HTP on the Injured Human Spinal Cord

Drug
General health
Online since 5 November 2021, updated 959 days ago

About this trial

This trial is recruiting individuals with spinal cord injuries to study the effects of the drug 5-hydroxytryptophan (5-HTP) on spinal cord function. 5-HTP is a commonly used over-the-counter dietary supplement; it is broken down in the body to become serotonin. Serotonin is a chemical necessary for nerve signal transmission and therefore important for motor function in the spinal cord. The study will also look at the effect of carbidopa, a drug which may enhance the effects of 5-HTP. The study will measure nerve cell activity, reflexes and changes in motor performance during leg cycling in response to a single administration of drugs in 4 study segments: 1) carbidopa only (50mg); 2) 5-HTP (50mg) combined with carbidopa (50 mg); 3) 5-HTP (100 mg) combined with carbidopa (50mg); or 4) a placebo. Blood and serum samples will be obtained to measure levels of serotonin, serotonin related molecules, and cortisol. Each participant will receive all 4 interventions given in a randomized order; neither participant nor doctor will know which medication is given. If included in the trial, participants will complete a total of four lab visits.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    6 months - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have history of epilepsy, tumors, cardiovascular disease, liver disease or lung disease

    What’s involved

    Type

    Drug

    Details

    Four lab visits on different days Intake of study medications and assessment of blood samples, clinical tests, neurophysiology and motor tasks, lasting up to 150 minutes after the dose of study medications.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Spasticity

    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
    • 1 Jul 2020
    • Organisation
    • University of Alberta
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jul 2020
    • Organisation
    • University of Alberta

    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