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

Jazz Pharmaceuticals

Status

Not yet enrolling

Conditions

Tuberous Sclerosis Complex

Dravet Syndrome

Lennox Gastaut Syndrome

Treatments

Drug: Epidiolex 100 mg/mL Oral Solution

Study type

Observational

Funder types

Industry

Identifiers

NCT05485831

JZP926-525

Details and patient eligibility

About

This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 52 weeks of treatment.

Full description

This observational study evaluates a Real-World population of children and adult participants affected by LGS, DS, and TSC and the effect of therapy with Epidyolex® administered according to clinical practice on epileptic symptoms. The study will assess specific scales, questionnaires, and the satisfaction of the caregivers and the participants/tutors.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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.