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RECRUITINGOBSERVATIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form/assent for participation in the study. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Epidiolex 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