Cannabis-based medicine eases seizures in Dravet syndrome
A phase III clinical trial has shown the cannabis-based medicine Epidiolex® (cannabidiol oral solution) to reduce seizures in children with Dravet syndrome, a rare and severe form of childhood-onset epilepsy.
Sydney Children’s Hospital, Randwick, was one of two sites in Australia to take part in the international study, which reinforced the safety and efficacy of the drug in reducing seizures in children with the condition.
In this trial, Epidiolex®, which is manufactured by UK-based GW Pharmaceuticals, or a placebo was given along with the child’s regular anti-epileptic medication.
Participants who were given Epidiolex® saw a reduction in convulsive seizures of nearly 50 percent, compared to a 27 percent reduction in patients taking placebo. A secondary outcome measured in the study was a measure of change as reported by the participant’s caregiver, who scored an increased improvement in their children that was of statistical significance when compared to the placebo group.
“This is more evidence supporting an anti-epilepsy effect of cannabidiol oral solution in children with the rare, severe and often life-threatening epilepsy, Dravet syndrome. This is another important step as we learn the benefits, side effects and dose of this drug for children," said Dr John Lawson, neurologist at Sydney Children’s Hospital.
The success of this latest Dravet trial follows the US approval of Epidiolex by the FDA in June 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older. The results may lead to future TGA approval for use in Australia and the product is currently under regulatory review in Europe with a decision expected in Q1 2019.