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New treatment option for Spinal Cord Injuries
Official title Effects of 5HTP on the Injured Human Spinal Cord
ClinicalTrials.gov ID: NCT04520178
What this study is testing
What is 5-Hydroxytryptophan 100 MG?
5-Hydroxytryptophan 100 MG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for spinal cord injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- participants must have suffered trauma to the spinal cord at least six months ago or longer
You likely can't join if
- 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
See the full eligibility criteria
- participants must have suffered trauma to the spinal cord at least six months ago or longer
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States; Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.