Testing 5-Hydroxytryptophan against a placebo for spinal cord injuries
Official title: Effects of 5HTP on the Injured Human Spinal Cord
Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord
- Phase 2
- 4 groups
- One site, in Edmonton
- Recruiting
Interventions (4)
- Medication
5-Hydroxytryptophan 100 MG
100mg combined with 50mg carbidopa
- Medication
5-Hydroxytryptophan
50mg combined with 50mg carbidopa
- Medication
Carbidopa
50mg
- Medication
Placebo
Placebo
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +participants must have suffered trauma to the spinal cord at least six months ago or longer
Exclusion
- −known or suspected allergy to the medication ingredients
- −individuals with damage to the nervous system other than to the spinal cord
- −alcoholic participants
- −history of seizure/epilepsy
- −history of suicidal thoughts or behaviors
- −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
- −anti-hypertensive drugs
- −iron salts
- −metoclopramide
- −phenothiazine medication
- −pregnant and/or breastfeeding women
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A, the comparison group, receives one or more of: 5-Hydroxytryptophan and Carbidopa.
Registry label: A: Low-dose 5HTP
Group B, the comparison group, receives one or more of: 5-Hydroxytryptophan 100 MG and Carbidopa.
Registry label: B: High-dose 5HTP
Group C, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Carbidopa.
Registry label: C: Carbidopa
Group D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: D: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in motoneuron excitability — measured over Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake.
Change in spinal excitability — measured over Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake.
Change in flexor reflex/spasms — measured over Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake.
Change in functional movement performance — measured over Pre drug-intake, 120-150minutes post drug-intake.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04520178 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 5-Hydroxytryptophan 100 MGDrug
100mg combined with 50mg carbidopa
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 5-HydroxytryptophanDrug
50mg combined with 50mg carbidopa
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarbidopaDrug
50mg
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake.
The study as a whole is currently expected to finish around 2026-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.