Effects of 5HTP and LDOPA on CNS Excitability After SCI

NCT04000919 | Suspended Phase 2 FDA Drug

• 1 other identifier: 18.1268
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• Change in corticospinal excitability

  Transcranial magnetic stimulation motor-evoked potentials

  Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake

• Change in motoneuron excitability

  F waves

  Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake

• Change in spinal excitability

  H reflex

  Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake

• Change in spasticity

  Cutaneomuscular reflex

  Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake

• Change in movement performance

  Leg cycling

  Pre drug-intake, 120-150minutes post drug-intake

Secondary Outcomes (7)

• Serum Analysis 5-HIAA

  90-120minutes post drug-intake

• Serum Analysis 5-HT

  90-120minutes post drug-intake

• Whole blood analysis 5-HT

  90-120minutes post drug-intake

• Serum analysis Cortisol

  90-120minutes post drug-intake

• Serum and Urine Analysis of dopamine

  90-120min post drug-intake

Study Arms (4)

Effects of single-dose of carbidopa (50mg) on CNS excitability

SHAM COMPARATOR

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

Effects of single-dose placebo on CNS Excitability

PLACEBO COMPARATOR

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

Effects of single-dose 5HTP/carbidopa on CNS Excitability

ACTIVE COMPARATOR

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

Effects of single-dose L-DOPA/carbidopa on CNS Excitability

ACTIVE COMPARATOR

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

Interventions

5HTP DRUG

5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)

Also known as: carbidopa

Effects of single-dose 5HTP/carbidopa on CNS Excitability

L-DOPA DRUG

L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)

Also known as: Sinemet, Carbidopa

Effects of single-dose L-DOPA/carbidopa on CNS Excitability

Placebo oral tablet DRUG

Placebo

Effects of single-dose placebo on CNS Excitability

Carbidopa DRUG

Carbidopa (50mg)

Effects of single-dose of carbidopa (50mg) on CNS excitability

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessica M D'Amico: lead

Study Sites (1)

University of Louisville, Kentucky Spinal Cord Injury Research Centre

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Carbidopa; Levodopa; carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Jessica D'Amico, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 27, 2019
• Study Start: June 19, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

US (1)