Evaluating the Safety and Efficacy of Full-Spectrum Medicinal Cannabis (FEN164) in Children with ASD

A recent study on the effects of a cannabis oil in children with Autism Spectrum Disorder (ASD), has shown promising results with 93% of participants reporting positive effects after 4 weeks.


The trial was conducted by Professor Michael Fahey at Monash Children’s hospital in Melbourne, Australia. This was A Phase I/II Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (tetrahydrocannabinol) in Children with Autism Spectrum Disorder (ASD). The researchers were interested in the safety of the product, and if there was a change in Anxiety, Depression, Mood, and sleep disturbances experienced by the children.


The participants were boys and girls aged 8 years to 17 years (inclusive), and had a diagnosis of Level 2 or 3 Autism Spectrum Disorder (ASD). To be accepted in this trial, children needed all their treatments including medications and therapies for ASD related symptoms to be stable for 4 weeks before enrolment and for the duration of the trial wherever possible. The children received a baseline dose of 5mg/kg/day, titrated up weekly by 5mg/kg for a period of 4 weeks until the maximum tolerated dose or 20mg/kg was achieved.


The scientists found that the children were communicating better, socialised more, they felt less anxious, and their meltdowns were less frequent.


So why is this information important? Based on international data, it is estimated between 1-2% of people in New Zealand are autistic. That’s between 50,000 to 100,000 people who see, hear and feel the world differently to other people and some people are affected more than others. For example, some autistic people do not use spoken language, while others have excellent spoken language skills but may find it difficult to understand what other people mean. Some autistic people also have Attention Deficit Hyperactivity Disorder (ADHD) and/or learning difficulties and others may also have anxiety and sleep disturbances.


Many of the drugs prescribed in autism spectrum disorder have limited supporting evidence and some have significant adverse effects so monitoring is required.


While this was a small study, the results were promising and no severe side-effects were encountered; without a doubt, this trial will be followed by larger studies.


In New Zealand, medicinal cannabis is an unregistered prescription medicine.


For more information, access the trial information here.