The Age 3 February 2016
Dozens of Victorian children with severe epilepsy will soon be able to test a cannabis-based drug in the hope it will treat their seizures.
The Austin Hospital in Melbourne is recruiting 60 children with intractable epilepsy to participate in a trial of cannabidiol (CBD) produced by an American pharmaceutical company called Insys Therapeutics Inc.
The drug is made from a synthetic version of CBD, a therapeutic compound found in the cannabis plant. The drug does not include tetrahydrocannabinol or THC – the psycho-active component of cannabis that gets people “stoned”.
The trial will test appropriate doses for 10 patients this year before researchers recruit 60 people aged one to 17 for ongoing treatment with either the drug or a placebo. The study will only be open to children with severe epilepsy who have tested at least three drugs that have failed.
The Victorian trial comes after the NSW Government last year announced children with severe epilepsy could access a medicinal cannabis drug called Epidiolex, which has shown positive results in US trials. NSW researchers are also testing a second cannabis-derived drug called CBDV.
The Austin Hospital’s director of paediatrics Ingrid Scheffer said the study would be Australia’s first double-blinded randomised controlled trial – the most reliable study design possible to establish whether the drug works. Neither the patients nor the researchers will know who received the real drug versus the placebo.