|Principal Investigator: Francis Filloux|
|Keywords: Pediatric Neurology , Epilepsy , cannabidiol||Department: Pediatric Neurology|
|IRB Number: 00072206||Co Investigator:|
|Sub Specialties: Epilepsy|
The primary objective of this study is to determine the tolerability and optimal dose of CBD as an adjunct treatment in children and young adults with drug resistant epilepsy. The study will use a pharmaceutical product (Epidiolex) produced by GW pharmaceuticals which contains CBD, with very low concentrations of other phytocannabinoids including THC.
- Documentation of a diagnosis of drug resistant epilepsy as evidenced by failure to control seizures despite appropriate trial of four or more AEDs at therapeutic doses. Documentation must include the diagnosis of epilepsy type or epilepsy syndrome (if possible), as well as the underlying cause, when known.
- Between 1-3 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. Vagus nerve stimulator (VNS), ketogenic diet and modified Atkins diet do not count toward this limit.
- VNS must be on stable settings for a minimum of 3 months.
- If on ketogenic diet, must be on stable ratio for a minimum of 3 months.
- Written informed consent obtained from the patient or the patient’s legal representative must be obtained prior to beginning treatment.
1. Treatment with any artisanal preparation containing or possibly containing CBD during the month before initiation of the study drug.