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出境医 / 临床实验 / Effects of 5HTP and LDOPA on CNS Excitability After SCI

Effects of 5HTP and LDOPA on CNS Excitability After SCI

Study Description
Brief Summary:
This study will examine whether supplementation with the serotonin and dopamine precursors, 5HTP and L-DOPA can alter central nervous system excitability and improve motor function after incomplete and complete spinal cord injuries.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: 5HTP Drug: L-DOPA Drug: Placebo oral tablet Drug: Carbidopa Phase 2 Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Both the participant and assessors are blinded to which drug/placebo the participant reviews because all drugs are housed in similar capsules. Only the PI and caregiver will be aware of which drug will be administered for safety purposes.
Primary Purpose: Basic Science
Official Title: The Effects of 5-hydroxytryptophan (5-HTP) and L-3,4-dihydroxyphenylalanine (L-DOPA) Supplementation on Central Nervous System Excitability and Motor Function in Individuals With Spinal Cord Injury
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 30, 2023
Arms and Interventions
Arm Intervention/treatment
Sham Comparator: 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.
 Drug: Carbidopa
Carbidopa (50mg)
Placebo Comparator: 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.
 Drug: Placebo oral tablet
Placebo
Active Comparator: 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.
 Drug: 5HTP
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
Other Name: carbidopa
Active Comparator: 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.
 Drug: L-DOPA
L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
Other Names:
  • Sinemet
  • Carbidopa
Outcome Measures
Primary Outcome Measures :
  1. Change in corticospinal excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    Transcranial magnetic stimulation motor-evoked potentials

  2. Change in motoneuron excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    F waves

  3. Change in spinal excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    H reflex

  4. Change in spasticity [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    Cutaneomuscular reflex

  5. Change in movement performance [ Time Frame: Pre drug-intake, 120-150minutes post drug-intake ]
    Leg cycling


Secondary Outcome Measures :
  1. Serum Analysis 5-HIAA [ Time Frame: 90-120minutes post drug-intake ]
    5-HIAA (serum)

  2. Serum Analysis 5-HT [ Time Frame: 90-120minutes post drug-intake ]
    5-HT (serum)

  3. Whole blood analysis 5-HT [ Time Frame: 90-120minutes post drug-intake ]
    5-HT (whole blood)

  4. Serum analysis Cortisol [ Time Frame: 90-120minutes post drug-intake ]
    Cortisol level

  5. Serum and Urine Analysis of dopamine [ Time Frame: 90-120min post drug-intake ]
    catecholamines and homovanillic acid (urine)

  6. Serum Catechloamines [ Time Frame: 90-120minutes post drug-intake ]
    catecholamines and homovanillic acid (urine)

  7. Urine Homovanillic acid [ Time Frame: 90-120minutes post drug-intake ]
    homovanillic acid (urine)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged 18-65 years of age.
  • 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:

  • Individuals with damage to the nervous system other than to the spinal cord
  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jessica D'Amico, PhD 15025827443 jessica.damico@louisville.edu

Locations
Layout table for location information
United States, Kentucky
University of Louisville, Kentucky Spinal Cord Injury Research Centre Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jessica D'Amico, PhD         
Principal Investigator: Jessica D'Amico, PhD         
Sub-Investigator: David Rouffet, PhD         
Sponsors and Collaborators
Jessica M D'Amico
Investigators
Layout table for investigator information
Principal Investigator: Jessica D'Amico, PhD University of Louisville
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Change in corticospinal excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    Transcranial magnetic stimulation motor-evoked potentials
  • Change in motoneuron excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    F waves
  • Change in spinal excitability [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    H reflex
  • Change in spasticity [ Time Frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake ]
    Cutaneomuscular reflex
  • Change in movement performance [ Time Frame: Pre drug-intake, 120-150minutes post drug-intake ]
    Leg cycling
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Corticospinal excitability [ Time Frame: Pre drug-intake, 30min, 60min, 90min, 120min and 150min post drug-intake ]
    Transcranial magnetic stimulation motor-evoked potentials
  • Motoneuron excitability [ Time Frame: Pre drug-intake, 30min, 60min, 90min, 120min and 150min post drug-intake ]
    F waves
  • Spinal excitability [ Time Frame: Pre drug-intake, 30min, 60min, 90min, 120min and 150min post drug-intake ]
    H reflex
  • Spasticity [ Time Frame: Pre drug-intake, 30min, 60min, 90min, 120min and 150min post drug-intake ]
    Cutaneomuscular reflex
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2020)
  • Serum Analysis 5-HIAA [ Time Frame: 90-120minutes post drug-intake ]
    5-HIAA (serum)
  • Serum Analysis 5-HT [ Time Frame: 90-120minutes post drug-intake ]
    5-HT (serum)
  • Whole blood analysis 5-HT [ Time Frame: 90-120minutes post drug-intake ]
    5-HT (whole blood)
  • Serum analysis Cortisol [ Time Frame: 90-120minutes post drug-intake ]
    Cortisol level
  • Serum and Urine Analysis of dopamine [ Time Frame: 90-120min post drug-intake ]
    catecholamines and homovanillic acid (urine)
  • Serum Catechloamines [ Time Frame: 90-120minutes post drug-intake ]
    catecholamines and homovanillic acid (urine)
  • Urine Homovanillic acid [ Time Frame: 90-120minutes post drug-intake ]
    homovanillic acid (urine)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		Serum and Urine Analysis of serotonin and dopamine [ Time Frame: 150min post drug-intake ]
5-HIAA (serum), 5-HTP (serum and whole blood), catecholamines and homovanillic acid (urine)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of 5HTP and LDOPA on CNS Excitability After SCI
Official Title  ICMJE The Effects of 5-hydroxytryptophan (5-HTP) and L-3,4-dihydroxyphenylalanine (L-DOPA) Supplementation on Central Nervous System Excitability and Motor Function in Individuals With Spinal Cord Injury
Brief Summary This study will examine whether supplementation with the serotonin and dopamine precursors, 5HTP and L-DOPA can alter central nervous system excitability and improve motor function after incomplete and complete spinal cord injuries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Both the participant and assessors are blinded to which drug/placebo the participant reviews because all drugs are housed in similar capsules. Only the PI and caregiver will be aware of which drug will be administered for safety purposes.
Primary Purpose: Basic Science
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Drug: 5HTP
    5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
    Other Name: carbidopa
  • Drug: L-DOPA
    L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
    Other Names:
    • Sinemet
    • Carbidopa
  • Drug: Placebo oral tablet
    Placebo
  • Drug: Carbidopa
    Carbidopa (50mg)
Study Arms  ICMJE
  • Sham Comparator: 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.
    Intervention: Drug: Carbidopa
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo oral tablet
  • Active Comparator: 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.
    Intervention: Drug: 5HTP
  • Active Comparator: 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.
    Intervention: Drug: L-DOPA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals aged 18-65 years of age.
  • 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:

  • Individuals with damage to the nervous system other than to the spinal cord
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica D'Amico, PhD 15025827443 jessica.damico@louisville.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000919
Other Study ID Numbers  ICMJE 18.1268
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jessica M D'Amico, University of Louisville
Study Sponsor  ICMJE Jessica M D'Amico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jessica D'Amico, PhD University of Louisville
PRS Account University of Louisville
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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