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Precursor

Effects of single-dose 5HTP/carbidopa on CNS Excitability for Spinal Cord Injury

Phase 2 & 3
Waitlist Available
Led By Jessica D'Amico, PhD
Research Sponsored by Jessica M D'Amico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
Awards & highlights

Study Summary

This trial will investigate whether taking 5HTP and L-DOPA, which are precursors to serotonin and dopamine, can improve motor function and nervous system excitability after spinal cord injuries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre drug-intake, 30minutes, 60minutes, 90minutes, 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 corticospinal excitability
Change in motoneuron excitability
Change in movement performance
+2 more
Secondary outcome measures
Serum Analysis 5-HIAA
Serum Analysis 5-HT
Serum Catechloamines
+4 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Effects of single-dose 5HTP/carbidopa on CNS ExcitabilityActive Control1 Intervention
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.
Group II: Effects of single-dose L-DOPA/carbidopa on CNS ExcitabilityActive Control1 Intervention
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.
Group III: Effects of single-dose placebo on CNS ExcitabilityPlacebo Group1 Intervention
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.
Group IV: Effects of single-dose of carbidopa (50mg) on CNS excitabilityPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Jessica M D'AmicoLead Sponsor
Jessica D'Amico, PhDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of 5HTP and LDOPA on CNS Excitability After SCI
Jessica M D'Amico 2019. "Effects of 5HTP and LDOPA on CNS Excitability After SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04000919.
~5 spots leftby Apr 2025
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