Clinical Cannabis trial for children with Autism
An Israeli startup will be testing its cannabis-based treatments on children with autism.
SciSparc aims to alleviate anxiety, sleep problems, hyperactivity, and other symptoms associated with the disorder.
It will conduct a clinical trial to assess the safety, tolerability, and efficacy of its drug SCI-210, a combination of CBD (an ingredient in cannabis that eases anxiety, chronic pain and inflammation) and one of the company’s pain-relieving tablets.
Sixty children will participate in the 20-week trial, and in order to reliably test the drug’s efficacy, they will receive either the real treatment or placebo for a time, and then be switched to the opposite treatment.
Caregivers and clinicians will assess the severity of the symptoms they experienced before and after the trial.
The trial will be conducted at the Soroka University Medical Center, in Be’er Sheva, southern Israel, after securing approvals from the Israeli Ministry of Health as well as the medical center’s ethics committee.
Some studies have already shown that cannabis products can reduce the number and/or intensity of different symptoms associated with autism, including attacks of self-mutilation and anger, sleep problems, anxiety, restlessness, irritability, and depression.
They also found an improvement in cognition, attention, social interaction, and language. The most common adverse effects from using cannabis products were sleep disorders, restlessness, nervousness and change in appetite.
Israeli manufacturer of cannabis-based products, Tikun Olam Cannbit Pharmaceuticals, will supply SciSparc with CBD oil for its treatment.
“We are nearing the end of our preparations to begin our clinical trial on children with autism spectrum disorder. Our partners are chosen for their experience, quality, and deep knowledge in the relevant fields,” said Oz Adler, CEO of SciSparc.
“Since clinical trials on children are extremely strict, and it is one of the populations most in need of these treatments, we are proud of the approvals we have received so far.”
