NCT05485831

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lennox Gastaut Syndrome
• Dravet Syndrome
• Tuberous Sclerosis Complex

Interventions

Type	Name	Description
DRUG	Epidiolex 100 mg/mL Oral Solution	As prescribed in routine clinical practice in Italy.

Timeline

• Start date: 2025-02-24
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2022-08-03
• Last updated: 2026-02-17

Locations

18 sites across 1 country: Italy