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Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
Sponsor: Jazz Pharmaceuticals
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.
Official title: 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)
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-02-24
Completion Date
2027-02
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
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