Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dravet Syndrome | — | UNRESOLVED | — |
| Lennox Gastaut Syndrome | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epidiolex 100 mg/mL Oral Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Lennox Gastaut, Dravet Syndrome, and Tuberous Sclerosis Complex
- description
- Participants ≥2 years of age diagnosed with LGS, DS, and TSC.
- interventionNames
- Drug: Epidiolex 100 mg/mL Oral Solution
Primary outcomes (1)
- measure
- Number of Participants Remaining on Therapy from Enrollment
- timeFrame
- Baseline up to Week 52 post-dose.
- description
- 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 \[V5\]).
Secondary outcomes (16)
- measure
- Average Number of Seizure-Free Days in the Last 28 Days
- timeFrame
- Weeks 4 (V1), 16 (V2), 28 (V3), 40 (V4) and 52 (V5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 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.
References
Publications (0)
Data not yet available