Status:
RECRUITING
Effects of 5HTP on the Injured Human Spinal Cord
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Wings for Life
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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. Participa...
Detailed Description
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...
Eligibility Criteria
Inclusion
- participants must have suffered trauma to the spinal cord at least six months ago or longer
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04520178
Start Date
July 1 2020
End Date
December 30 2026
Last Update
August 27 2025
Active Locations (2)
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1
University of Louisville
Louisville, Kentucky, United States, 40292
2
University of Alberta
Edmonton, Alberta, Canada, T6G-2E1