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Effects of 5HTP on the Injured Human Spinal Cord

Study acronym: 5-HTP only
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 4 entries Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 6 participants (planned 30)
    • Primary completion date changed from estimate of Jun 30, 2026 to May 13, 2026
    • Eligibility criteria expanded, about 36 words
    • Study description revised
    • Site details revised at 2 of 2 sites
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    v7
  3. Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v6
  4. Trial status: Active, Not Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Jun 30, 2023 to Jun 30, 2024
    • Study completion date: Jun 30, 2024 to Dec 30, 2024
    • Secondary endpoints revised (4)
    • Site details revised at 2 of 2 sites
  5. Lead sponsor: University of Louisville to University of Albertav4 Show 6 more changesShow less
    • Primary completion date: Jun 30, 2022 to Jun 30, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 2
    • Study completion date: Jun 30, 2023 to Jun 30, 2024
    • Study description expanded, about 265 words
    • Collaborators expanded, about 3 words
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Primary endpoints revised (4)
    • Secondary endpoints: 1 to 4
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will assess how the serotonin precursor, 5-HTP, alter nervous system excitability and motor function in individuals with spinal cord injuries of differing chronicity and severity. Participants will visit the lab on 4 separate occasions where they will be administered four different drugs in a randomized, double-blinded, placebo-controlled crossover design.
Trial Details
NCT Number NCT04520178
Lead Sponsor University of Alberta
Collaborators: Wings for Life
Conditions
(from sponsor)		 Spinal Cord Injuries
Related terms Spinal Cord Injuries
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov