RecruitingNCT05485831

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)


Sponsor

Jazz Pharmaceuticals

Enrollment

100 participants

Start Date

Feb 24, 2025

Study Type

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

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following patients in Italy who are starting treatment with Epidyolex (a prescription cannabis-based medicine containing cannabidiol/CBD) for one of three serious epilepsy conditions: Lennox-Gastaut Syndrome (LGS), Dravet Syndrome, or Tuberous Sclerosis Complex (TSC). The goal is to track how well it works in real-world clinical practice. **You may be eligible if...** - You are an adult, or a child aged 2 or older - You have been diagnosed with Lennox-Gastaut Syndrome, Dravet Syndrome, or Tuberous Sclerosis Complex - Your doctor has made the clinical decision to start you on Epidyolex as part of your regular care - You (or your parent/guardian) are willing and able to give consent **You may NOT be eligible if...** - You have used recreational cannabis, medical cannabis, or other cannabinoid products in the past 3 months and are unwilling to stop during the study - Your doctor determines Epidyolex is not appropriate based on safety warnings (such as certain liver function abnormalities) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpidiolex 100 mg/mL Oral Solution

As prescribed in routine clinical practice in Italy.


Locations(18)

Policlinico Sant'Orsola di Bologna

Bologna, Italy

NPI AOU Mater Domini Università Magna Graecia

Catanzaro, Italy

Università degli studi "G. D'annunzio" Chieti

Chieti, Italy

Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica

Florence, Italy

Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari

Genova, Italy

AOU Gaetano Martino

Messina, Italy

Centro Regionale Epilessia - ASST Santi Paolo e Carlo

Milan, Italy

ASST Grande Ospedale metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

AOU Maggiore della Carità di Novara

Novara, Italy

AOU di Padova

Padova, Italy

Policlinico Tor Vergata

Roma, Italy

IRCCS Ospedale Pediatrico Bambin Gesù

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI

Roma, Italy

Azienda Ospedaliero Universitaria Sant'Andrea

Roma, Italy

Ospedale Casa del sollievo e della sofferenza

San Giovanni Rotondo, Italy

AOU Città della Salute PO Molinette

Torino, Italy

Azienda Ospedaliero Universitaria delle Marche

Torrette, Italy

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NCT05485831


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