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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.

Protocol: GWEP1424

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.

Exclusion Criteria:

* 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.

 



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