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Serotonin precursor probed for spinal cord injury effects

NCT ID NCT04520178

Symptom relief Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at the University of Alberta are testing whether 5-HTP, a serotonin precursor, can change nerve excitability and motor function in people with spinal cord injuries. The trial enrolls six adults who sustained a spinal cord injury at least six months earlier. In a randomized, double-blinded, placebo-controlled crossover design, participants visit the lab four times to receive different drug combinations or placebo, while researchers measure reflexes, muscle responses, and leg cycling performance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-HTP (5-hydroxytryptophan), a serotonin precursor, given with carbidopa
What this could lead to
If 5-HTP safely changes nerve excitability, it could point toward a drug approach to help movement or reduce spasms after spinal cord injury.
What could go wrong
This is a very small, early-phase study of six participants, so any signal may not hold up in larger trials. 5-HTP can cause nausea, drowsiness, or serotonin-related side effects, and the trial excludes people with seizures, heart conditions, or suicidal history.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

6 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries

Contacts and locations

Locations

  • University of Alberta

    Edmonton, Alberta, T6G-2E1, Canada

  • University of Louisville

    Louisville, Kentucky, 40292, United States

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