NCT05485831Active, not recruiting
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
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)
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 111 (actual)
- First submitted
- 29 Jul 2022
- Start date
- 24 Feb 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Jazz Pharmaceuticals
- Diseases
- Epilepsy
- NCT number
- NCT05485831
What you commit to
- Study type: Observational
- Participants enrolled: 111
- From 24 Feb 2025 to the primary completion date, Feb 2027
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- Any reason, according to Investigator's judgment, able to compromise compliance with procedures outlined in the study There will not be any other specific exclusion criteria; however, contraindications, special warnings, and precautions for use as detailed in the Summary of Product Characteristics (SmPC) (particularly related to raising of aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin) will have to be considered by the treating physician.
Who the study is looking for
- 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.
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Sant'Orsola di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| NPI AOU Mater Domini Università Magna Graecia Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Università degli studi "G. D'annunzio" Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| AOU Gaetano Martino Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Centro Regionale Epilessia - ASST Santi Paolo e Carlo Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AOU Maggiore della Carità di Novara Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| AOU di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Sant'Andrea Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS Ospedale Pediatrico Bambin Gesù Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale Casa del sollievo e della sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| AOU Città della Salute PO Molinette Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Azienda Ospedaliero Universitaria delle Marche Coordinator of this site? Confirm its status | Torrette | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.