5-Hydroxytryptophan 100 MG
Drug100mg combined with 50mg carbidopa
NCT Number: NCT04520178
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
University of Alberta, Edmonton, Alberta, Canada
This study will assess for the first time the effects of 5-HTP on neural excitability utilizing a combination of neurophysiological and functional testing in subacute motor complete (AIS A/B), chronic motor complete (AIS A/B) and chronic incomplete (AIS C/D) SCI participants. To reduce peripheral side effects such as nausea, these supplements will be co-administered with carbidopa which inhibits the action of peripheral AADC, thereby ensuring that 5-HTP can effectively cross the blood brain barrier prior to being broken down. The neurophysiological outcomes will allow for the determination of the mechanistic actions of each pharmacological agent on different pathways/sites within the central nervous system in three different patient populations with varying degrees of lesion severity and will for the determination of whether increased Amino Acid Decarboxylase (AADC) expression and therefore the efficacy of this approach is correlated to lesion severity and/or chronicity. Importantly, the use of functional testing will allow for the determination of whether these often-reported neurophysiological changes translate to improvements in muscle activation patterns and kinematics during cycling.
The effects of 5-HTP will be assessed across three different participant groups: i) subacute (6 months-1 year) AIS A/B SCI individuals, ii) chronic (>2 years post injury) AIS A/B SCI individuals and iii) chronic AIS C/D SCI individuals.. In a placebo-controlled, randomized crossover design, participants will receive i) 50 mg 5HTP combined with 50 mg carbidopa, ii) 100 mg 5-HTP combined with 50 mg carbidopa, iii) 50 mg carbidopa only or iv) placebo. Ten participants will be recruited in each group. Participants will visit the lab on four separate occasions, separated by at least 72 hours.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants taking:
100mg combined with 50mg carbidopa
50mg combined with 50mg carbidopa
50mg
Placebo
Time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake
F waves
Time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake
H reflex
Time frame: Pre drug-intake, 30minutes, 60minutes, 90minutes and 120minutes post drug-intake
Cutaneomuscular reflex
Time frame: Pre drug-intake, 120-150minutes post drug-intake
Leg cycling task
Time frame: 90-120minutes post drug-intake
5-HIAA (serum)
Time frame: 90-120minutes post drug-intake
5-HT (serum and whole blood), cortisol
Time frame: 90-120minutes post drug-intake
serum cortisol
Time frame: 90-120minutes post drug-intake
Blood 5HT
Contact information is provided by the study sponsor or research team.
University of Alberta
Other
Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord
Acronym: 5-HTP only
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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