Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY

Launched by JAZZ PHARMACEUTICALS · Aug 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of Epidyolex®, a medication derived from cannabis, in patients with Lennox Gastaut Syndrome (LGS), Dravet Syndrome (DS), or Tuberous Sclerosis Complex (TSC). The trial aims to observe how effective Epidyolex® is when given to approximately 70-100 participants over a period of 52 weeks. This study is taking place in Italy and is currently recruiting participants.

To be eligible for this study, participants need to be either adults or children aged 2 years and older who have been diagnosed with LGS, DS, or TSC and for whom their doctor has decided to start treatment with Epidyolex®. Participants, or their guardians, must also be willing to provide consent to join the study. Throughout the trial, participants can expect regular check-ins with their doctors, who will monitor their health and how well the medication is working. It's important to note that participants cannot be using other cannabis products during the study period, and certain health conditions will be considered by the doctors before enrolling anyone in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients, and minor patients ≥ 2 years old diagnosed with LGS, DS or TSC.
• • Clinical decision, taken by the physician, to initiate Epidyolex®
• • Adult participants, parents or legal representatives must be willing and able to give informed consent/assent for participation in the study.
• Exclusion Criteria:
• • Participants currently using or have used recreational, medicinal cannabis, or cannabinoid-based products within the three months prior to study entry and are unwilling to abstain from these products for the duration of the study.
• • Any reason, according to Investigator's judgment, able to compromise compliance with procedures outlined in the study There will not be any other specific exclusion criteria; however, contraindications, special warnings, and precautions for use as detailed in the Summary of Product Characteristics (SmPC) (particularly related to raising of aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin) will have to be considered by the treating physician.