Effects of 5HTP on the Injured Human Spinal Cord

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Alberta
Study ID
NCT04520178
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-Hydroxytryptophan 100 MG — DRUG
    100mg combined with 50mg carbidopa
  • 5-Hydroxytryptophan — DRUG
    50mg combined with 50mg carbidopa
  • Carbidopa — DRUG
    50mg
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jul 1, 2020
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Low-dose 5HTP
    50mg 5-HTP in combination with 50mg carbidopa
  • Active Comparator: High-dose 5HTP
    100mg 5-HTP in combination with 50mg carbidopa
  • Sham Comparator: Carbidopa
    50mg carbidopa only
  • Placebo Comparator: Placebo
    Placebo comparator

Primary Outcome Measure

Change in motoneuron excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40292-

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By research site
University of Louisville· Louisville, KY

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