Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
EpiTALY
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)
1 other identifier
observational
100
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedStudy Start
First participant enrolled
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 17, 2026
February 1, 2026
1.9 years
July 29, 2022
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Remaining on Therapy from Enrollment
Treatment retention will be evaluated through the proportion of participants remaining on therapy from the enrollment visit (baseline, V0) to each study visit (Weeks 4 \[V1\], 16 \[V2\], 28 \[V3\], 40 \[V4\], 52 \[V5\]).
Baseline up to Week 52 post-dose.
Secondary Outcomes (16)
Average Number of Seizure-Free Days in the Last 28 Days
Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5)
Longest Duration of Seizure Free Days in the Last 28 Days
Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5)
Average Maintenance Dose of Epidyolex®
Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5)
Maximum Maintenance Dose of Epidyolex®
Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5)
Type, Dosage, and Frequency of Concomitant Anti-Seizure Medications (ASMs)
Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5)
- +11 more secondary outcomes
Study Arms (1)
Lennox Gastaut, Dravet Syndrome, and Tuberous Sclerosis Complex
Participants ≥2 years of age diagnosed with LGS, DS, and TSC.
Interventions
As prescribed in routine clinical practice in Italy.
Eligibility Criteria
The study will comprise of 70-100 male and female participants, aged ≥ 2 years, diagnosed with LGS, DS, and TSC. The decision to prescribe Epidyolex® as adjunctive therapy for seizures associated with LGS, DS, and TSC will be entirely independent of including the participant in the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jazz Pharmaceuticalslead
- Advice Pharma Group srlcollaborator
Study Sites (18)
Policlinico Sant'Orsola di Bologna
Bologna, 40138, Italy
NPI AOU Mater Domini Università Magna Graecia
Catanzaro, 88100, Italy
Università degli studi "G. D'annunzio" Chieti
Chieti, 66100, Italy
Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica
Florence, 50139, Italy
Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari
Genova, 16147, Italy
AOU Gaetano Martino
Messina, 98124, Italy
Centro Regionale Epilessia - ASST Santi Paolo e Carlo
Milan, 20142, Italy
ASST Grande Ospedale metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
AOU Maggiore della Carità di Novara
Novara, 28100, Italy
AOU di Padova
Padua, 35128, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
IRCCS Ospedale Pediatrico Bambin Gesù
Roma, 00165, Italy
Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI
Roma, 00168, Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189, Italy
Ospedale Casa del sollievo e della sofferenza
San Giovanni Rotondo, 71013, Italy
AOU Città della Salute PO Molinette
Torino, 10126, Italy
Azienda Ospedaliero Universitaria delle Marche
Torrette, 60126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 3, 2022
Study Start
February 24, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share