INSYS Therapeutics has started a Phase ll clinical trial of cannabidiol (CBD) oral solution to treat refractory childhood absence epilepsy in paediatric patients.
The open-label, dose-finding study is called INS011-17-103 that aims to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of CBD to help control treatment-resistant ‘staring’ seizures in children with epilepsy.
The trial is expected to be completed in late-2018.
Mary Bridge Children’s Hospital and Health Center pediatric neurologist and the study investigator Dr Steven Phillips said: “Treatment options for pediatric epilepsy patients with refractory childhood absence seizures are limited and inadequate.
“Better treatments with greater efficacy and fewer side-effects are needed to improve quality of life and clinical outcomes for these patients.
“CBD holds great promise for this challenging form of epilepsy, and we are excited to be involved in another study of this particularly promising formulation of CBD from INSYS.”
The Center for Disease Control and Prevention (CDC) and Epilepsy Foundation have estimated that out of the more than 470,000 children in the US who have been diagnosed with epilepsy, 2%–8% have experienced absence seizures.
INSYS previously completed a Phase l/ll clinical trial of CBD oral solution for the treatment of refractory pediatric epilepsy.
The majority of patients in the trial and long-term safety studies are found to have experienced a reduction in seizure frequency and/or intensity while receiving CBD oral solution.