Clinical Trials

Inclusion Criteria

• Male or female
• Between ages 2 and 18 years inclusive
• Must have a documented history of Dravet syndrome which is not completely controlled by current antiepileptic drugs
• Must be taking one or more antiepileptic drugs at a dose which has been stable for at least four weeks
• All medications or interventions for epilepsy including ketogenic diet and vagus nerve stimulation must have been stable for four weeks prior to screening and subject is willing to maintain a stable regimen throughout the study

Exclusion Criteria

• Clinically significant unstable medical conditions other than epilepsy
• Clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy
• Currently or in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry and is unwilling to abstain for the duration for the study
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products
• Plans to travel outside country of residence during the study
• Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia Suicide Severity Rating Scale (Children's) at screening