5-HTP + Carbidopa for Spinal Cord Injury
(5-HTP only Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants taking specific drugs like antidepressants, amphetamines, and some blood pressure medications, among others. It's important to discuss your current medications with the trial team to see if any need to be stopped.
What evidence supports the effectiveness of the drug 5-HTP + Carbidopa for spinal cord injury?
Is 5-HTP combined with Carbidopa safe for humans?
There is limited safety data specifically for the combination of 5-HTP and Carbidopa in humans, but 5-HTP is generally considered safe when used appropriately, and Carbidopa is commonly used in combination with other medications for Parkinson's disease. However, individual responses can vary, and it's important to consult with a healthcare provider before starting any new treatment.12346
How does the drug 5-HTP + Carbidopa differ from other treatments for spinal cord injury?
Research Team
Jessica D'Amico, PhD
Principal Investigator
University of Alberta
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive different doses of 5-HTP and carbidopa or placebo in a randomized, double-blinded, placebo-controlled crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 5-Hydroxytryptophan (Serotonin Precursor)
- Carbidopa (Dopa Decarboxylase Inhibitor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Bill Flanagan
University of Alberta
Chief Executive Officer since 2020
LLB from University of Toronto, LLM from Columbia University
Dr. Verna Yiu
University of Alberta
Chief Medical Officer since 2012
MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University
University of Louisville
Lead Sponsor
Wings for Life
Collaborator