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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

Be older than 18 years old

Must not have

History of tumors

Reduced kidney function or disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had tumors in the past.

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I have kidney problems.

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I have a history of seizures or epilepsy.

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I am currently taking medication that affects my central nervous system.

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My bone marrow is not functioning properly.

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I am currently taking levodopa.

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I have been diagnosed with wide angle glaucoma.

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I have a history of heart disease, including heart attacks or irregular heartbeats.

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I have had stomach ulcers in the past.

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My liver is not working properly.

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I am currently taking medication for depression or Parkinson's disease.

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I have been diagnosed with coronary artery disease.

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I have heart problems that are not well-managed.

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I am currently taking medication that affects serotonin levels.

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I am currently taking iron supplements.

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I am not in a coma or severely depressed due to medications.

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I am currently taking lithium.

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I have been diagnosed with phenylketonuria.

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I am currently taking antidepressants that affect serotonin.

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I am currently taking amphetamine.

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I am currently taking metoclopramide.

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I have a blood disorder.

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I am currently taking tricyclic antidepressants.

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I am currently taking phenothiazine medication.

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I am currently taking medication that affects dopamine in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake

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.