Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 2, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
PANS Pediatric Acute-Onset Neuropsychiatric Syndrome
Interventions
DRUG

NTI164

This intervention uses Full-Spectrum Medicinal Cannabis Plant Extract with a low THC concentration of 0.08% (NTI164), specifically formulated to treat pediatric acute-onset neuropsychiatric syndrome (PANS). The dosing regimen is carefully structured to increase from an initial 5 mg/kg per day up to a maximum of 20 mg/kg, tailored to individual tolerance levels. This gradual titration and the option to extend treatment up to 54 weeks distinguishes it from other interventions that may use different concentrations of THC or shorter treatment durations. The efficacy of NTI164 is rigorously assessed through psychological evaluations and biomarker analyses.

Trial Locations (2)

2145

The Childrens Hospital at Westmead, Sydney

Unknown

Monash Children's Hospital, Melbourne

Sponsors
All Listed Sponsors
collaborator

Neurotech International Limited

INDUSTRY

lead

Fenix Innovation Group

INDUSTRY