Actively Recruiting
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
Led by Jazz Pharmaceuticals · Updated on 2026-02-17
100
Participants Needed
18
Research Sites
101 weeks
Total Duration
On this page
Sponsors
J
Jazz Pharmaceuticals
Lead Sponsor
A
Advice Pharma Group srl
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, and minor patients 2 years old diagnosed with LGS, DS or TSC.
- Clinical decision, taken by the physician, to initiate Epidyolex400 mg/mL oral solution.
- Adult participants, parents or legal representatives must be willing and able to give informed consent/assent for participation in the study.
You will not qualify if you...
- 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.
- Contraindications, special warnings, and precautions for use as detailed in the Summary of Product Characteristics (SmPC), particularly related to liver function markers (AST, ALT, and total bilirubin), must be considered by the treating physician.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Policlinico Sant'Orsola di Bologna
Bologna, Italy, 40138
Actively Recruiting
2
NPI AOU Mater Domini Università Magna Graecia
Catanzaro, Italy, 88100
Actively Recruiting
3
Università degli studi "G. D'annunzio" Chieti
Chieti, Italy, 66100
Actively Recruiting
4
Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica
Florence, Italy, 50139
Actively Recruiting
5
Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari
Genova, Italy, 16147
Actively Recruiting
6
AOU Gaetano Martino
Messina, Italy, 98124
Actively Recruiting
7
Centro Regionale Epilessia - ASST Santi Paolo e Carlo
Milan, Italy, 20142
Actively Recruiting
8
ASST Grande Ospedale metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
9
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, 80131
Actively Recruiting
10
AOU Maggiore della Carità di Novara
Novara, Italy, 28100
Actively Recruiting
11
AOU di Padova
Padova, Italy, 35128
Actively Recruiting
12
Policlinico Tor Vergata
Roma, Italy, 00133
Actively Recruiting
13
IRCCS Ospedale Pediatrico Bambin Gesù
Roma, Italy, 00165
Actively Recruiting
14
Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI
Roma, Italy, 00168
Actively Recruiting
15
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, Italy, 00189
Actively Recruiting
16
Ospedale Casa del sollievo e della sofferenza
San Giovanni Rotondo, Italy, 71013
Actively Recruiting
17
AOU Città della Salute PO Molinette
Torino, Italy, 10126
Actively Recruiting
18
Azienda Ospedaliero Universitaria delle Marche
Torrette, Italy, 60126
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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