18
Participants
Start Date
June 2, 2023
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
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.
The Childrens Hospital at Westmead, Sydney
Monash Children's Hospital, Melbourne
Collaborators (1)
Neurotech International Limited
INDUSTRY
Fenix Innovation Group
INDUSTRY