ENROLLING NOW - 5
5. A randomized, double-blind, placebo- controlled study to investigate the safety and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet Syndrome.
PI: Eric Segal, MD
Sponsor: GW Pharma
Key Inclusion Criteria:
* Male or female aged between two and 18 years (inclusive).
* Patient must have a documented history of DS which is not completely controlled by current AEDs.
* Patient must be experiencing four or more convulsive seizures (i.e., tonic-clonic, tonic, clonic, atonic seizures) during the 28-day baseline observation period.
* Patient must be taking one or more AEDs at a dose which has/have been stable for at least four weeks.
* Patient and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements
* All medications or interventions for epilepsy (including ketogenic diet and VNS) must have been stable for four weeks prior to screening and patient and caregiver are willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments are not counted as an AED.
* Patient has clinically significant unstable medical conditions other than epilepsy.
* Patient has any concurrent cardiovascular conditions which will, in the investigator's opinion, interfere with the ability to assess their ECGs.
* Patient is currently using, or has in the past used, recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the three months prior to study entry.
* Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMPs (e.g., sesame oil).
* Patient is taking felbamate and they have been taking it for less than one year prior to screening.