5-HTP only: Effects of 5HTP on the Injured Human Spinal Cord

• Sponsor: University of Louisville (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04520178
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Drug: 5-Hydroxytryptophan 100 MG; Drug: 5-Hydroxytryptophan; Drug: Carbidopa; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low-dose 5HTP 50mg 5-HTP in combination with 50mg carbidopa	Drug: 5-Hydroxytryptophan; 50mg combined with 50mg carbidopa; Drug: Carbidopa; 50mg
Active Comparator: High-dose 5HTP 100mg 5-HTP in combination with 50mg carbidopa	Drug: 5-Hydroxytryptophan 100 MG; 100mg combined with 50mg carbidopa; Drug: Carbidopa; 50mg
Sham Comparator: Carbidopa 50mg carbidopa only	Drug: Carbidopa; 50mg
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Change in motoneuron excitability [Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake]

   F waves

2. Change in spinal excitability [Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake]

   H reflex

3. Change in flexor reflex/spasms [Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake]

   Cutaneomuscular reflex

4. Change in functional movement performance [Pre drug-intake, 120-150minutes post drug-intake]

   Leg cycling task

Secondary Outcome Measures

1. Serum analysis of 5HIAA [90-120minutes post drug-intake]

   5-HIAA (serum)

2. Serum analysis of serotonin [90-120minutes post drug-intake]

   5-HT (serum and whole blood), cortisol

3. Serum analysis of cortisol [90-120minutes post drug-intake]

   serum cortisol

4. Whole blood analysis of Serotonin [90-120minutes post drug-intake]

   Blood 5HT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville, Kentucky Spinal Cord Injury Research Centre	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville

Investigators

• Principal Investigator: Jessica D'Amico, PhD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica M D'Amico, Assistant Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT04520178
• Other Study ID Numbers: 18.1268-Aim 2
• First Posted: Aug 20, 2020
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Cord Injuries; Carbidopa; 5-Hydroxytryptophan

Study Results

No Results Posted as of Aug 30, 2021