Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)
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.
Timeline
- Start
- 2023-06-02
- Primary completion
- 2025-12
- Completion
- 2025-12
Outcome
Met primary endpoint
release “NTI164 has shown statistically significant efficacy in impr oving the symptoms associated with PANDAS/PANS after 12 weeks of daily therapy, with the trial meeting” investi.com.au ↗
release “Primary endpoint of anxiety and depression (RCADS -P) met (p=0.016) with a 30% improvement in” investi.com.au ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NTI164 | Traditional medicine (herbal / TCM) | 20 mg/kg | — |