Effects of 5HTP and LDOPA on CNS Excitability After SCI
NCT ID: NCT04000919
Last Updated: 2022-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2019-06-19
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Effects of single-dose of carbidopa (50mg) on CNS excitability
Participants will visit the lab and on one of four different occasions they will receive carbidopa only (50 mg). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
Carbidopa
Carbidopa (50mg)
Effects of single-dose placebo on CNS Excitability
Participants will visit the lab and on one of four different occasions and will receive a placebo. Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
Placebo oral tablet
Placebo
Effects of single-dose 5HTP/carbidopa on CNS Excitability
During one of the four occasions participants visit the lab they will receive 5HTP combined with carbidopa (50-200mg HTP/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
5HTP
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
Effects of single-dose L-DOPA/carbidopa on CNS Excitability
During one of the four occasions participants visit the lab they will receive L-DOPA combined with carbidopa (50-200mg L-DOPA/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake.
L-DOPA
L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
Interventions
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5HTP
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
L-DOPA
L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
Placebo oral tablet
Placebo
Carbidopa
Carbidopa (50mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have suffered a trauma to the spinal cord at least 1 year ago or longer.
* Patients must exhibit some degree of spasticity which can be self-reported (Penn spasm frequency) or if assessed by a physiotherapist, a modified Ashworth spasticity score greater than 1
Exclusion Criteria
* Pregnant or breastfeeding women
* Alcoholic patients
* Patients with a history of seizures or epilepsy
* Patients with a history of suicidal thoughts or behaviors
* Patients with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
* Patients with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
* Patients with:
* Known or suspected allergy to the medication or the ingredients
* Cardiovascular disease including history of heart attack or heart rhythm irregularities
* Coronary artery disease
* Comatose or depressed states due to CNS depressants
* Endocrine dysfunction
* Blood dyscrasias
* Bone marrow depression
* History of seizures
* Hypocalcemia
* History of stomach ulcers
* Wide-angle glaucoma
* Phenylketonuria
Patients taking:
* Monoamine oxidase inhibitor therapy
* Serotonergic antidepressants: selective serotonin and norepinephrine reuptake inhibitors
* Tricyclic antidepressants
* Any type of serotonergic agonist
* Dopamine D2 receptor antagonists
* Amphetamine
* CNS depressants
* Levodopa
* Lithium
* Anti-hypertensive drugs (Carbidopa and L-DOPA)
* Iron salts
* Metoclopramide
* Phenothiazine medication
18 Years
65 Years
ALL
No
Sponsors
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Jessica M D'Amico
OTHER
Responsible Party
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Jessica M D'Amico
Assistant Professor
Principal Investigators
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Jessica D'Amico, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville, Kentucky Spinal Cord Injury Research Centre
Louisville, Kentucky, United States
Countries
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Other Identifiers
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18.1268
Identifier Type: -
Identifier Source: org_study_id
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