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NCT Number: NCT04520178

Effects of 5HTP on the Injured Human Spinal Cord

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

This study will assess for the first time the effects of 5-HTP on neural excitability utilizing a combination of neurophysiological and functional testing in subacute motor complete (AIS A/B), chronic motor complete (AIS A/B) and chronic incomplete (AIS C/D) SCI participants. To reduce peripheral side effects such as nausea, these supplements will be co-administered with carbidopa which inhibits the action of peripheral AADC, thereby ensuring that 5-HTP can effectively cross the blood brain barrier prior to being broken down. The neurophysiological outcomes will allow for the determination of the mechanistic actions of each pharmacological agent on different pathways/sites within the central nervous system in three different patient populations with varying degrees of lesion severity and will for the determination of whether increased Amino Acid Decarboxylase (AADC) expression and therefore the efficacy of this approach is correlated to lesion severity and/or chronicity. Importantly, the use of functional testing will allow for the determination of whether these often-reported neurophysiological changes translate to improvements in muscle activation patterns and kinematics during cycling.

The effects of 5-HTP will be assessed across three different participant groups: i) subacute (6 months-1 year) AIS A/B SCI individuals, ii) chronic (>2 years post injury) AIS A/B SCI individuals and iii) chronic AIS C/D SCI individuals.. In a placebo-controlled, randomized crossover design, participants will receive i) 50 mg 5HTP combined with 50 mg carbidopa, ii) 100 mg 5-HTP combined with 50 mg carbidopa, iii) 50 mg carbidopa only or iv) placebo. Ten participants will be recruited in each group. Participants will visit the lab on four separate occasions, separated by at least 72 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants must have suffered trauma to the spinal cord at least six months ago or longer

Exclusion criteria

  • individuals with damage to the nervous system other than to the spinal cord
  • pregnant and/or breastfeeding women
  • alcoholic participants
  • history of seizure/epilepsy
  • history of suicidal thoughts or behaviors
  • known or suspected allergy to the medication ingredients
  • cardiovascular disease including history of heart attack or heart rhythm irregularities
  • coronary artery disease
  • reduced liver function or disease
  • reduced kidney function or disease
  • lung disease
  • comatose or depressed states due to CNS depressants
  • endocrine dysfunction
  • blood dyscrasias or blood related disease
  • bone marrow depression
  • hypocalcemia
  • history of stomach ulcers
  • wide angle glaucoma
  • phenylketonuria
  • history of tumors
  • uncontrolled heart problems
  • unstable psychiatric or mental disorder

Participants taking:

  • monoamine oxidase inhibitor therapy
  • serotonergic antidepressants
  • tricyclic antidepressants
  • any type of serotonergic agonist
  • dopamine D2 receptor antagonists
  • amphetamine
  • CNS depressants
  • levodopa
  • lithium
  • anti-hypertensive drugs
  • iron salts
  • metoclopramide
  • phenothiazine medication

Treatment and study plan

5-Hydroxytryptophan 100 MG

Drug

100mg combined with 50mg carbidopa

5-Hydroxytryptophan

Drug

50mg combined with 50mg carbidopa

Carbidopa

Drug

50mg

Placebo

Drug

Placebo

Primary outcomes

  1. Change in motoneuron excitability

    Time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake

    F waves

  2. Change in spinal excitability

    Time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake

    H reflex

  3. Change in flexor reflex/spasms

    Time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake

    Cutaneomuscular reflex

  4. Change in functional movement performance

    Time frame: Pre drug-intake, 120-150minutes post drug-intake

    Leg cycling task

Secondary outcomes

  1. Serum analysis of 5HIAA (UofL Cohort only)

    Time frame: 90-120minutes post drug-intake

    5-HIAA (serum)

  2. Serum analysis of serotonin (UofL Cohort only)

    Time frame: 90-120minutes post drug-intake

    5-HT (serum and whole blood), cortisol

  3. Serum analysis of cortisol (UofL Cohort only)

    Time frame: 90-120minutes post drug-intake

    serum cortisol

  4. Whole blood analysis of Serotonin (UofL Cohort only)

    Time frame: 90-120minutes post drug-intake

    Blood 5HT

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica D'Amico, PhD

CONTACT

[email protected]

780-735-7917

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Wings for Life

Registry information

Official study title

Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord

Acronym: 5-HTP only

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2020
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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