29.09.2023 14:57:30
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SciSparc Initiates SCI-210 Clinical Trial In Pediatrics With Autism Spectrum Disorder
(RTTNews) - SciSparc Ltd. (SPRC), an Israeli specialty clinical-stage pharmaceutical company focused on disorders and rare disease of the central nervous system, Friday said it has initiated a pivotal clinical trial for its drug candidate, SCI-210, at the Soroka University Medical Center.
In pre-market activity on Nasdaq, SciSparc shares were gaining around 6 percent.
SCI-210 is designed to help control symptoms of Autism Spectrum Disorder or ASD. It is an innovative proprietary combination of cannabidiol or CBD and SciSparc's Palmitoylethanolamide or PEA, the active ingredient of its proprietary CannAmide.
The trial was designed in collaboration with the National Autism Research Center, Israel's institution for autism research.
ASD is a neurodevelopmental condition that profoundly impacts social interaction and communication skills.
The company said the study will evaluate the safety, tolerability, and efficacy of SCI-210, in comparison to CBD monotherapy in treating ASD. The randomized, double-blind, placebo-controlled trial with a cross-over study will span 20 weeks and involve 60 children between 5-18 years old.
The trial's primary efficacy endpoints include three rigorous assessments. They are the Aberrant Behavior Checklist-Community or ABC-C parent questionnaire; the Clinical Global Impressions-Improvement or CGI-I scale, administered by healthcare professionals; and the determination of the effective therapeutic dosage.
Regarding the significance of the trial, Oz Adler, Chief Executive Officer of SciSparc, stated, "The initiation of this clinical trial signifies a major leap forward in our collective effort to understand and effectively treat ASD. … Our goals are to create an effective and safe treatment for ASD and to improve the quality of life for these children and their families. We are optimistic that SCI-210 could be a game-changer in ASD treatment."
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