Neurotech International Ltd has received Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA) to commence a Phase I/II clinical trial of NTI164, a novel oral full-spectrum cannabinoid drug formulation, in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).
The trial will recruit 15 paediatric patients to assess the efficacy and safety of NTI164 over a 12-week period, with all patients eligible to continue to receive treatment for up to 54 weeks.
The primary endpoints are the change from baseline at twelve (12) weeks for the Revised Children’s Anxiety and Depression Scale-Parent-rated (RCADS-P) score and Clinical Global Impression (CGI) of severity (CGI-S) and improvement (CGI-I).
The trial is being conducted at two centres within Australia; the Children’s Hospital at Westmead and the Paediatric Neurology Unit at Monash Medical Centre.
Recruitment of the 15 patients is anticipated to commence during Q1 CY2023, with results of the trial anticipated in 2H CY2023.