New Phase II Study in Israel Will Use Test Cannabinoids and their Effect on Autism Spectrum Disorder

Building on an earlier trial with cannabinoids as a treatment for autism spectrum disorder behavior symptoms (ASD), pediatric neurologist Adi Aran, MD, the study’s principal investigator, recently elaborated on a new, follow-up trial (1). The main objective of this 12-week, double-blind, randomized Phase II clinical trial is to test the neuroprotective cannabinoid therapeutic from GCANRx on ASD symptoms in children (2).

“Autism is an umbrella term for many different problems,” Dr. Aran explained (1). “We want to see which children this treatment is helping the most, and to find which component [of cannabis] we have to give them, and at what concentration. We have a lot of work ahead of us.”

Dr. Aran’s first trial began in 2017 and involved 150 patients ages 5–21 with low- to medium-functioning autism spectrum disorder (ASD) (1). The 12-week trial was the first-ever randomized, double-blind, placebo-controlled clinical trial on cannabinoids for treating children’s ASD (1). In this trial (1), the patients received a 20:1 ratio of either a whole plant extract with cannabinol (CBD), delta-9-tetrahydrocannabinol (THC), and additional compounds like terpenes and flavonoids, or a purified CBD and THC. Some received a placebo. After a 4-week break, the treatment groups were switched.

“We saw that half of the children improved in both the cannabinoid arms, while in the placebo, only one-fifth of the children improved,” said Dr. Aran (1). “We didn’t see a substantial difference between the whole plant extract and the pure cannabinoid, at least in our experiment. Maybe future studies will prove us wrong. Maybe they’ll find that, indeed, there is an ‘entourage effect.’”

The Phase II trial, which will last around two years begin possibly in December 2023, will involve 100 children between ages 4 and 12 (1). The decision to study a different age group, Dr. Aran explained, was due to seeing greater effects in younger children (1). In addition to similar treatments of the 2017 trial, the new study will involve new, undisclosed components and vitamins already shown to help with ASD symptoms (1).

“Currently, we cannot give everything in one solution,” Dr. Aran explained (1). “Probably in the future, we will be able to, but for now, we will need to give [study participants] ‘component A,’ and then ‘component B.’”

GCANRx (Greater Cannabis Company Inc), announced earlier this year its funding for the Phase two trial and the approval from the Israel Ministry of Health (2). “Positive results in this study carry promise for a novel treatment for ASD as well as for other neuropsychiatric disorders such as schizophrenia, Alzheimer's disease, and Parkinson’s disease, which share similar pathophysiological processes, and can have an enormous impact on the lives of countless families as well as on public health,” Aitan Zacharin, Chief Executive Officer of GCANRx said (2).

A press release from CGCANRx stated that 1.5 million people in the US are using CBD to treat ASD and 22.6% of parents use CBD to treat ASD symptoms in their child (2).

References

1. Luxner, L. Israeli neurologist launches follow-up trial on cannabinoid-based therapy for children with autism https://www.endocannabinoidmedicine.com/features/israeli-neurologist-launches-follow-up-trial-on-cannabinoid-based-therapy-for-children-with-autism/ (accessed Oct 5, 2023).
2. GCANRx Announces Approval of Phase II Clinical Trial to Treat Autism Related Spectrum Disorders. GlobeNewsWire. July 5, 2023.