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

Last updated: February 13, 2026
Sponsor: Jazz Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Seizure Disorders (Pediatric)

Neurofibromatosis

Scar Tissue

Treatment

Epidiolex 100 mg/mL Oral Solution

Clinical Study ID

NCT05485831
JZP926-525
  • Ages > 2
  • All Genders

Study 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 Criteria

Inclusion

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 togive informed consent/assent for participation in the study.

Exclusion

Exclusion Criteria:

  • Participants currently using or have used recreational, medicinal cannabis, orcannabinoid-based products within the three months prior to study entry and areunwilling to abstain from these products for the duration of the study.

  • Any reason, according to Investigator's judgment, able to compromise compliance withprocedures outlined in the study There will not be any other specific exclusioncriteria; however, contraindications, special warnings, and precautions for use asdetailed in the Summary of Product Characteristics (SmPC) (particularly related toraising of aspartate aminotransferase [AST], alanine aminotransferase [ALT], andtotal bilirubin) will have to be considered by the treating physician.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Epidiolex 100 mg/mL Oral Solution
Phase:
Study Start date:
February 24, 2025
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Policlinico Sant'Orsola di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Policlinico Sant'Orsola di Bologna

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • NPI AOU Mater Domini Università Magna Graecia

    Catanzaro, 88100
    Italy

    Site Not Available

  • NPI AOU Mater Domini Università Magna Graecia

    Catanzaro 2525059, 88100
    Italy

    Active - Recruiting

  • Università degli studi "G. D'annunzio" Chieti

    Chieti, 66100
    Italy

    Site Not Available

  • Università degli studi "G. D'annunzio" Chieti

    Chieti 3178796, 66100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica

    Firenze, 50139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica

    Florence 3176959, 50139
    Italy

    Active - Recruiting

  • Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari

    Genova, 16147
    Italy

    Site Not Available

  • Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari

    Genova 8969657, 16147
    Italy

    Active - Recruiting

  • AOU Gaetano Martino

    Messina, 98124
    Italy

    Site Not Available

  • AOU Gaetano Martino

    Messina 2524170, 98124
    Italy

    Active - Recruiting

  • ASST Grande Ospedale metropolitano Niguarda

    Milan 6951411, 20162
    Italy

    Active - Recruiting

  • Centro Regionale Epilessia - ASST Santi Paolo e Carlo

    Milan 6951411, 20142
    Italy

    Active - Recruiting

  • ASST Grande Ospedale metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Centro Regionale Epilessia - ASST Santi Paolo e Carlo

    Milano, 20142
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • AOU Maggiore della Carità di Novara

    Novara, 28100
    Italy

    Site Not Available

  • AOU Maggiore della Carità di Novara

    Novara 3172189, 28100
    Italy

    Active - Recruiting

  • AOU di Padova

    Padova, 35128
    Italy

    Site Not Available

  • AOU di Padova

    Padua 3171728, 35128
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI

    Roma, 00168
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambin Gesù

    Roma, 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù (OPBG)

    Roma, 00152
    Italy

    Site Not Available

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Sant'Andrea

    Roma 8957247, 00189
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI

    Roma 8957247, 00168
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambin Gesù

    Roma 8957247, 00165
    Italy

    Active - Recruiting

  • Policlinico Tor Vergata

    Roma 8957247, 00133
    Italy

    Active - Recruiting

  • Ospedale Casa del sollievo e della sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Ospedale Casa del sollievo e della sofferenza

    San Giovanni Rotondo 3168234, 71013
    Italy

    Active - Recruiting

  • AOU Città della Salute PO Molinette

    Torino, 10126
    Italy

    Site Not Available

  • AOU Città della Salute PO Molinette

    Torino 8980539, 10126
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Torrette 8960841, 60126
    Italy

    Active - Recruiting

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