A clinical trial of a CBD-based drug in patients with autism spectrum disorder (ASD) has received approval from Israel’s Ministry of Health.
The trial will investigate the effect of the drug SCI-210 from the pharmaceutical company SciSparc in the treatment of ASD.
SCI-210 is a proprietary combination of cannabidiol (CBD) and CannAmide™, a compound that regulates endocannabinoid levels by enhancing receptor sensitivity and inhibiting their metabolism.
The announcement comes shortly after the company received approval from the Be’er-Sheva University Soroka Medical Center Ethics Committee to conduct the trial.
The objectives of the trial are to evaluate the safety, tolerability, and efficacy of SCI-210 in children and adolescents with ASD in a 20-week, randomized, double-blind, crossover clinical trial of 60 children.
The placebo-controlled trial has three main efficacy goals: the Aberrant Behavior Checklist-Community (ABC-C) questionnaire for parents, the Clinical Global Impressions-Improvement (CGI-I) and the effective therapeutic dose.
Oz Adler, Chief Executive Officer of SciSparc, commented: “We are pleased to achieve another important milestone that brings us one step closer to the start of our clinical trial in ASD.
“Symptoms of ASD in pediatric patients can lead to a severe decrease in quality of life, for parents and children.
“We believe our unique and patented SCI-210 has the potential to be a novel treatment for reducing irritability and other conditions associated with ASD.”
He added: “Patients today have limited treatment options, while the need for this treatment is growing rapidly.
“Our drug candidates allow us to offer an effective, safer and more tolerable treatment with fewer side effects thanks to the lower doses of cannabinoids, enhanced by the combination with CannAmide™, a mission that is always desirable, but even more so when children are the target population. .”
ASD is a condition related to brain development that affects the way a person perceives and socializes with others, causing potential difficulties in social interaction and communication.
The term “spectrum” in autism spectrum disorder refers to the wide range of symptoms and severity.
The launch of the trial is pending further approvals from the Israeli Medical Cannabis Agency.
SciSparc is currently involved in several drug development programs covering Tourette syndrome, Alzheimer’s disease and pain.
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