The move comes following approvals from the Israeli Medical Cannabis Agency (IMCA) at the Israeli Ministry of Health and the Soroka University Medical Center Ethics Committee.
The placebo-controlled, randomised, double-blind trial will compare the tolerability, efficacy, and safety of SCI-210 against CBD alone in children with ASD.
Its design includes a cross-over, double-blind, placebo-controlled, randomised study of 60 children with ASD, assessed for 20 weeks.
The Clinical Global Impressions-Improvement (CGI-I) performed by a clinician, the Aberrant Behavior Checklist-Community parent questionnaire, and the effective therapeutic dose are the primary efficacy endpoints of the study.
SciSparc CEO Oz Adler said: “The initiation of this clinical trial represents a significant step forward for our proprietary SCI-210 as we work to develop a novel treatment for children and adolescents with ASD.
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“Given there are very few safe and effective treatments for reducing ASD symptoms, we believe that SCI-210 potentially introduces a safe and effective solution to this condition, which represents a clear unmet medical need.
“We hope the outcome of the trial will enable the company to proceed with the commercialisation process for SCI-210 in Israel.”
SciSparc intends to further commercialise SCI-210 globally in various regions, upon receiving respective regulatory approvals.
The study design was planned in consultation with the National Autism Research Center in Israel.
The company is also engaged in developing various therapeutics for treating pain, Alzheimer’s disease and agitation, ASD, status epilepticus, and Tourette Syndrome.