SciSparc Ltd. (Nasdaq: SPRC) has renewed its approval from the Israeli Medical Cannabis Agency (IMCA) to continue its clinical trial of SCI-210, a CBD and CannAmide™ combination, for children with autism spectrum disorder (ASD). This renewal allows SciSparc to proceed with its ongoing double-blind, placebo-controlled study at Soroka University Medical Center, involving 60 children aged 5 to 18. The trial aims to assess the efficacy and safety of SCI-210 compared to standard CBD monotherapy, using measures like the Aberrant Behavior Checklist-Community (ABC-C) and the Clinical Global Impressions-Improvement (CGI-I) scale.
This continued trial is crucial for advancing potential ASD treatments. Current therapeutic options for ASD are often limited, and many families seek alternative or complementary therapies. Positive results from this trial could validate the combined use of CBD and CannAmide™, paving the way for a new, potentially more effective treatment option for managing ASD symptoms. This research contributes significantly to understanding the potential benefits and risks of cannabinoid-based therapies for children with ASD.
The clinical trial, conducted in consultation with Israel’s National Autism Research Center, employs a 20-week treatment program focusing on symptom management. Key data points will include the ABC-C parent questionnaire, the CGI-I scale, and determining an effective therapeutic dose for SCI-210. Pending positive outcomes and regulatory approvals, SciSparc intends to commercialize SCI-210 initially in Israel and subsequently expand internationally.
The renewal of the IMCA approval reinforces the validity of SciSparc’s research and its potential to impact the lives of children with ASD and their families. Positive clinical trial results could accelerate the development and adoption of cannabinoid-based therapies for ASD, creating new markets and potentially improving treatment outcomes for a significant patient population. This trial’s progress will be closely monitored by both the scientific community and families seeking effective ASD treatments.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.