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Serotonin Precursor

5-HTP + Carbidopa for Spinal Cord Injury (5-HTP only Trial)

Phase 2 & 3
Recruiting
Led By Jessica D'Amico, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have suffered trauma to the spinal cord at least six months ago or longer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake
Awards & highlights

5-HTP only Trial Summary

This trial will study the effects of 5-HTP on nerve function and movement in people with spinal cord injuries of varying degrees of severity.

Who is the study for?
This trial is for individuals who have had a spinal cord injury at least six months ago. It's not suitable for those with kidney or liver disease, heart issues, psychiatric disorders, epilepsy, glaucoma, blood diseases, endocrine dysfunction, stomach ulcers or those on certain medications like antidepressants and CNS depressants.Check my eligibility
What is being tested?
The study tests how 5-HTP affects nervous system activity and motor skills in people with spinal cord injuries. Participants will take four different treatments (including a placebo) across four visits in a randomized order without knowing which one they're receiving each time.See study design
What are the potential side effects?
Possible side effects of the drugs tested may include gastrointestinal discomforts such as nausea or diarrhea; sleep disturbances; mood changes; muscle pain; and potential interactions with other medications leading to more serious conditions.

5-HTP only Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a spinal cord injury more than six months ago.

5-HTP only Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in flexor reflex/spasms
Change in functional movement performance
Change in motoneuron excitability
+1 more
Secondary outcome measures
Serum analysis of 5HIAA (UofL Cohort only)
Serum analysis of cortisol (UofL Cohort only)
Serum analysis of serotonin (UofL Cohort only)
+1 more

5-HTP only Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: High-dose 5HTPActive Control2 Interventions
100mg 5-HTP in combination with 50mg carbidopa
Group II: Low-dose 5HTPActive Control2 Interventions
50mg 5-HTP in combination with 50mg carbidopa
Group III: CarbidopaPlacebo Group1 Intervention
50mg carbidopa only
Group IV: PlaceboPlacebo Group1 Intervention
Placebo comparator

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,928 Total Patients Enrolled
Wings for LifeOTHER
6 Previous Clinical Trials
823 Total Patients Enrolled
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,954 Total Patients Enrolled

Media Library

5-Hydroxytryptophan (Serotonin Precursor) Clinical Trial Eligibility Overview. Trial Name: NCT04520178 — Phase 2 & 3
Spinal Cord Injury Research Study Groups: Carbidopa, High-dose 5HTP, Low-dose 5HTP, Placebo
Spinal Cord Injury Clinical Trial 2023: 5-Hydroxytryptophan Highlights & Side Effects. Trial Name: NCT04520178 — Phase 2 & 3
5-Hydroxytryptophan (Serotonin Precursor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520178 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other cases where 5HTP has been studied at a small dosage?

"5HTP was first studied at Academic Medical Center in 2014. Since then, there have been 18335 completed studies. As of now, there are 14 active clinical trials, with many of these taking place in Edmonton, Alberta."

Answered by AI

How is 5HTP commonly employed in patients?

"A standard treatment for parkinsonism post encephalitic is Low-dose 5HTP. This medication is also commonly used to mitigate the symptoms of parkinson disease, manganese intoxication, and levodopa-driven nausea and vomiting."

Answered by AI

Are there any prerequisites to enrolling in this research project?

"Up to 30 patients that have experienced a spinal cord injury, and are between 18-65 years old, can participate in this study. Key inclusion criteria for patients include: participants must have suffered their spinal cord injury at least six months ago."

Answered by AI

Are there any available slots for this research project?

"You are correct, the clinical trial described is not currently enrolling patients. The trial was posted on 2020-07-01 and updated on 2022-10-13, according to clinicaltrials.gov. There are, however, 384 other trials that are still recruiting."

Answered by AI

What are the benefits that researchers hope to gain from this clinical trial?

"The primary objectives of this study, which will be measured at pre-drug baseline and 120-150 minutes post-drug administration, is to investigate changes in motoneuron excitability. Secondary outcome measures include 5HIAA (serum), 5-HT (serum and whole blood), cortisol, and serum cortisol levels."

Answered by AI

Will this experiment be testing any treatments on elderly individuals?

"Eligibility criteria for this study includes being between 18-65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
University of Louisville, Kentucky Spinal Cord Injury Research Centre
University of Alberta
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I want human welfare before death.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Effects of 5HTP on the Injured Human Spinal Cord
Jessica M D'Amico 2020. "Effects of 5HTP on the Injured Human Spinal Cord". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520178.
All > Spinal Cord Injury
~1 spots leftby Jun 2024
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