Greater Cannabis Company (GCANRx) has received approval from the Israel Ministry of Health to initiate a Phase II clinical trial of its neuroprotective cannabinoid therapeutic to treat autism spectrum disorder (ASD).
Evaluating the safety, tolerability, and efficacy of the therapeutic in paediatric patients aged between four and 13 years is the primary objective of the placebo-controlled, double-blind study.
They will be randomised into a 1:1 ratio to receive the daily therapeutic orally or placebo.
Evaluating the therapeutic effect on behavioural problems against placebo using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I) score, change from baseline to week 12, is the primary efficacy objective.
In addition, evaluating absolute and relative frequencies of serious adverse events in groups treated with the therapeutic and placebo is the primary safety objective of the study.
The study’s secondary objective demonstrates the effect of the therapeutic and placebo on the core ASD symptoms.
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Changes from baseline to week 12 on ASD symptoms will be measured using Social Responsiveness Scale 2nd edition (SRS-II) total score and the Vineland Adaptive Behavior Scales (3rd edition, VABS3)- 2-Domain Composite Score.
The study is anticipated to start enrolling patients in the upcoming weeks.
GCANRx CEO Aitan Zacharin said: “Positive results in this study carry promise for a novel treatment for ASD, as well as for other neuropsychiatric disorders such as schizophrenia, Alzheimer’s disease, and Parkinson’s disease, which share similar pathophysiological processes and can have an enormous impact on the lives of countless families, as well as on public health.
“GCANRx’s therapeutic represents a promising candidate in our pipeline, leveraging cutting-edge research and scientific advancements.”