SciSparc and the Soroka University Medical Center Israel have signed an agreement for a clinical trial of drug candidate SCI-210 in patients with autism spectrum disorder (ASD), a condition related to brain development.
Last year, SciSparc received approval from the Israeli Ministry of Health and the Ethics Committee of the Soroka University Medical Center to conduct the study.
The clinical trial has been designed to evaluate the safety and effects of SciSparc’s SCI-210 against CBD monotherapy for the treatment of ASD.
SCI-210 is a combination of cannabidiol and CannAmide.
SciSparc CEO Oz Adler said: “The trial in ASD strengthens the company’s advanced clinical programmes, alongside our phase IIb clinical trial for SCI-110 in patients with Tourette Syndrome and the phase IIa clinical trial of SCI-110 in patients with Alzheimer’s disease and agitation.
“We are honoured to collaborate with Soroka Medical Center, a leading medical centre in Israel which co-established and is a partner of the Israeli National Centre for Autism and Neurodevelopment Research, a leading international center for innovation in translational research, diagnosis, and interventions in ASD and other neurodevelopmental conditions.”
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The objectives of the trial are to assess SCI-210’s tolerability, safety, and efficacy in children with ASD in a randomised, double-blind, placebo controlled with cross-over study.
It will be carried out in 60 children for 20 weeks.
The Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the effective therapeutic dose, and the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician are the three primary efficacy end points of the trial.
In August last year, SciSparc signed a clinical trial agreement with Yale University to add the Yale Child Study Center as a site for the Phase IIb trial of SCI-110 to treat Tourette Syndrome (TS).