SciSparc (SPRC) said Tuesday that the Israeli Medical Cannabis Agency at the Israeli Ministry of Health renewed an approval for the clinical trial of SCI-210 in children with autism spectrum disorder, or ASD.
The 30-day approval is expected to be extended upon final Israeli police approval, expected within the same timeframe, SciSparc said.
The SCI-210 clinical trial is a double-blind, randomized, placebo-controlled study at Soroka University Medical Center in Israel, involving 60 children aged 5 to18 with ASD, the pharmaceutical company said.
The 20-week trial will evaluate the efficacy and safety of SCI-210, which is a combination of a proprietary cannabidiol, or CBD, and CannAmide, against standard CBD therapy. The trial will focus on symptom management and therapeutic outcomes, SciSparc said, adding that it aims to launch SCI-210 in Israel first, with plans for international expansion pending regulatory approvals.
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