An Extension Study to Assess the Safety of the Use of Cannabidiol in Children and Young Adults with Dravet or Lennox-Gastaut Syndromes

Overview

About this study

The purpose of this extension study is to investigate the safety of using cannabidiol in children and young adults with Dravet or Lennox-Gastaut syndromes that are not well controlled.

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

  • Has completed all scheduled visits in the treatment phase of their Core Study

Exclusion Criteria

  • Is currently using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) other than the investigational medicinal product and is unwilling to abstain for the duration for the study
  • Any history of suicidal behavior or any suicidal ideation of type four or five on the C-SSRS at visit 1
  • Has been part of a clinical trial involving an investigational medicinal product during the inter-study period
  • Female subject is of child bearing potential or male subject's partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra uterine device, during the study and for three months thereafter (however a male condom should not be used in conjunction with a female condom)
  • Had significantly impaired hepatic function at the 'End of Treatment' visit of their Core Study or at visit 1 if re-assessed
    • Alanine aminotransferase [ALT] >5 x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN
    • ALT or aspartate aminotransferase (AST) >3 x ULN and TBL >2 x ULN or international normalized ratio [INR] >1.5
    • This criterion can only be confirmed once the laboratory results are available
      • Subjects that enter the study and are later found not to meet this criteria should be withdrawn from the study

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Amy Crepeau, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20179706

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