Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Basic Science
Participants needed
30 (estimated)
Sponsor
University of Alberta · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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/e…
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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