Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
Observational, Prospective, Multicenter Study of Epidyolex® (Cannabidiol CBD 100 mg/ml) Oral Solution, as Adjunctive Treatment for Seizures Associated With Lennox- Gastaut Syndrome (LGS), Dravet Syndrome (DS) and Tuberous Sclerosis Complex (TSC)
Jazz Pharmaceuticals
100 participants
Feb 24, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria1
- 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.
Interventions
As prescribed in routine clinical practice in Italy.
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT05485831