A Study to Investigate the Effectiveness and Safety of Cannabidiol in Children and Young Adults with Dravet Syndrome


About this study

The purpose of this study is to investigate the safety and potential antiepileptic effects of cannabidiol in children and young adults with Dravet syndrome

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Elaine Wirrell, M.D.

Closed for enrollment

More information


Publications are currently not available

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