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)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Policlinico Sant'Orsola di Bologna
RECRUITING
Bologna
NPI AOU Mater Domini Università Magna Graecia
RECRUITING
Catanzaro
Università degli studi G. D'annunzio Chieti
RECRUITING
Chieti
Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica
RECRUITING
Florence
Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari
RECRUITING
Genova
AOU Gaetano Martino
RECRUITING
Messina
ASST Grande Ospedale metropolitano Niguarda
RECRUITING
Milan
Centro Regionale Epilessia - ASST Santi Paolo e Carlo
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
NOT_YET_RECRUITING
Napoli
AOU Maggiore della Carità di Novara
RECRUITING
Novara
AOU di Padova
RECRUITING
Padua
Azienda Ospedaliero Universitaria Sant'Andrea
NOT_YET_RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI
RECRUITING
Roma
IRCCS Ospedale Pediatrico Bambin Gesù
RECRUITING
Roma
Policlinico Tor Vergata
RECRUITING
Roma
Ospedale Casa del sollievo e della sofferenza
RECRUITING
San Giovanni Rotondo
AOU Città della Salute PO Molinette
RECRUITING
Torino
Azienda Ospedaliero Universitaria delle Marche
NOT_YET_RECRUITING
Torrette
Contact Information
Primary
Clinical Trial Disclosure & Transparency
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2026-01
Participants
Target number of participants: 100
Treatments
Lennox Gastaut, Dravet Syndrome, and Tuberous Sclerosis Complex
Participants ≥2 years of age diagnosed with LGS, DS, and TSC.
Related Therapeutic Areas
Sponsors
Leads: Jazz Pharmaceuticals
Collaborators: Advice Pharma Group srl