Investigating the effects of Full-Spectrum medicinal cannabis plant extract 0.08% THC (NTI164) on paediatric acute-onset neuropsychiatric syndrome (PANS)

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1 - 17 years of age * Patients who fulfil PANS criteria * Acute onset of OCD or severely restricted food intake * Concurrent presentation of additional neuropsychiatric symptoms from at least 2 of the following 7 categories: anxiety, emotional lability/depression, irritability, aggression or severely oppositional behaviours, behavioural regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g. sleep disturbances, enuresis or increase in urinary frequency) * Symptoms not better explained by a known neurologic or medical disorder (e.g. Sydenham's chorea) * RCADS-P scores of \>65 (a scale of anxiety, social phobia, panic disorder, OCD, and low mood, a score of \>65 infers moderate-significant impairment) * Other patient medications (e.g. anti-psychotics) must be stable for at least 12 weeks prior to trial participation Exclusion Criteria: * Infection and/or antibiotic use in the 2 weeks prior to trial participation (i.e. baseline blood tests and commencement of NTI164) * Recent changes to other patient medication (e.g. addition or escalation of anxiolytics, anti-depressants etc; medication dosage must be stable for at least 12 weeks prior to trial participation) * Intellectual disability preventing adequate assent from patient, or that would affect reporting throughout trial; patients with intellectual disability must still have the capacity to verbalise their symptoms/experiences * Ongoing immunomodulating or immunosuppressive treatment use in the previous 12 weeks, including steroids, IVIG, antibiotics, low-dose naltrexone, mycophenolate, Rituximab etc. * Currently using or has used recreational or medicinal cannabis or cannabinoid-based medications (e.g. Sativex ®, Epidiolex ®) in the previous 12 weeks and/or is unwilling or unable to abstain for the duration of the trial * Underlying renal impairment, cardiovascular issues (e.g. arrhythmia), current or previous thrombosis * Impaired hepatic function, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN) or total bilirubin (TBL) \> 2 x ULN; this criterion can only be confirmed once baseline laboratory results are available and participants who fail this criterion will not proceed in this study * Other diagnosed neurological condition likely to be contributing to OCD/neuropsychiatric symptoms (e.g. Huntington's disease)