Clinical Trial

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

Study acronym: CannaPANS
Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated October 1, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
This study investigates the effectiveness of a medicinal cannabis extract (NTI164) with 0.08% THC in treating children with pediatric acute-onset neuropsychiatric syndrome (PANS) over a period of 18 to 54 weeks. Participants, aged 18 to 54, will start with a daily dose of 5mg/kg, gradually increasing to a maximum of 20mg/kg over four weeks. After reaching their maximum tolerated dose, they will maintain this dose for eight weeks, with an option to extend up to 54 weeks. The study will measure the treatment\'s efficacy using questionnaires on emotional and behavioral changes, and verify the results with whole blood RNA sequencing to assess immune dysfunction.
Trial Details
NCT Number NCT06621888
Lead Sponsor Fenix Innovation Group
Collaborators: Neurotech International Limited
Conditions PANS Pediatric Acute-Onset Neuropsychiatric Syndrome
Enrollment 18 participants
Start Date 2023-06-02
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-01