Spinal Cord InjuriesPhase 2/3NCT04000919
Effects of 5HTP and LDOPA on CNS Excitability After SCI
A Phase 2/3 study testing 5HTP, L-DOPA and Carbidopa in people with Spinal Cord Injuries, run by Jessica M D'Amico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- 5HTP, L-DOPA and Carbidopa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 30 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville, Kentucky Spinal Cord Injury Research Centre
Louisville, Kentucky, 40202
About this study
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
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
- Being tested
- 5HTP, L-DOPA, Placebo oral tablet, Carbidopa
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5HTPDrug
Also called carbidopa
5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
L-DOPADrug
Also called Sinemet, Carbidopa
L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
Placebo oral tabletDrug
Placebo
CarbidopaDrug
Carbidopa (50mg)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: L-DOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corticospinal excitability
Transcranial magnetic stimulation motor-evoked potentials
Measured: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Change in motoneuron excitability
F waves
Measured: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Change in spinal excitability
H reflex
Measured: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Change in spasticity
Cutaneomuscular reflex
Measured: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Change in movement performance
Leg cycling
Measured: Pre drug-intake, 120-150minutes post drug-intake
Secondary outcomes (7)
Serum Analysis 5-HIAA
5-HIAA (serum)
Measured: 90-120minutes post drug-intake
Serum Analysis 5-HT
5-HT (serum)
Measured: 90-120minutes post drug-intake
Whole blood analysis 5-HT
5-HT (whole blood)
Measured: 90-120minutes post drug-intake
Serum analysis Cortisol
Cortisol level
Measured: 90-120minutes post drug-intake
Serum and Urine Analysis of dopamine
catecholamines and homovanillic acid (urine)
Measured: 90-120min post drug-intake
Serum Catechloamines
catecholamines and homovanillic acid (urine)
Measured: 90-120minutes post drug-intake
Urine Homovanillic acid
homovanillic acid (urine)
Measured: 90-120minutes post drug-intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start19 Jun 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: PI left UofL and intends to reopen study at University of Alberta
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica M D'Amico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica M D'Amico, University of Louisville
- Investigators
- Jessica D'Amico, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000919
- Sponsor's protocol ID
- 18.1268
- Status last verified
- Oct 2022
- First submitted
- 19 Jun 2019
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04000919
- Acronym / sponsor ID
- 18.1268
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI left UofL and intends to reopen study at University of Alberta
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jessica M D'AmicoUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Effects of single-dose of carbidopa (50mg) on CNS excitability | Sham comparator | Drug: CarbidopaParticipants 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. |
| Effects of single-dose placebo on CNS Excitability | Placebo comparator | Drug: Placebo oral tabletParticipants 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. |
| Effects of single-dose 5HTP/carbidopa on CNS Excitability | Active comparator | Drug: 5HTPDuring 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. |
| Effects of single-dose L-DOPA/carbidopa on CNS Excitability | Active comparator | Drug: L-DOPADuring 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5HTPAlso: carbidopa5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa) | Drug | Effects of single-dose 5HTP/carbidopa on CNS Excitability |
| L-DOPAAlso: Sinemet, CarbidopaL-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa) | Drug | Effects of single-dose L-DOPA/carbidopa on CNS Excitability |
| Placebo oral tabletPlacebo | Drug | Effects of single-dose placebo on CNS Excitability |
| CarbidopaCarbidopa (50mg) | Drug | Effects of single-dose of carbidopa (50mg) on CNS excitability |
Primary outcome
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
7 secondary outcomes
Serum Analysis 5-HIAA
Time frame: 90-120minutes post drug-intake
Serum Analysis 5-HT
Time frame: 90-120minutes post drug-intake
Whole blood analysis 5-HT
Time frame: 90-120minutes post drug-intake
Serum analysis Cortisol
Time frame: 90-120minutes post drug-intake
Serum and Urine Analysis of dopamine
Time frame: 90-120min post drug-intake
Serum Catechloamines
Time frame: 90-120minutes post drug-intake
Urine Homovanillic acid
Time frame: 90-120minutes post drug-intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica D'Amico, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5HTP, L-DOPA and Carbidopa in people with Spinal Cord Injuries, run by Jessica M D'Amico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corticospinal excitability (time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.