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Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY

Study acronym: EpiTALY
StatusActive, Not Recruiting
PhaseNot specified
Started2025-02-24
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
Study Status, Study Design, Contacts/Locations v20
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment increased: 100 → 111 participants
Study sitesdetails revised at 18 of 18 sites
2026-02-13
Study Status v19
Primary completion date2026-01→2027-02
Completion date2026-01→2027-02
2025-12-24
Study Status, Contacts/Locations v18
Study sitesdetails revised at 3 of 18 sites
2025-09-23
Study Status, Contacts/Locations v17
Study sites15→18
2025-08-26
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 15 sites
Show 15 earlier versions
2025-07-03
Study Status, Contacts/Locations v15
Study sitesdetails revised at 3 of 15 sites
2025-05-19
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 15 sites
2025-05-07
Study Status, Outcome Measures, Contacts/Locations v13
Secondary endpointsdetails revised at 2 of 16 entries
Study sitesdetails revised at 1 of 15 sites
2025-04-10
Study Status, Contacts/Locations v12
Study sitesdetails revised at 4 of 15 sites
2025-03-11
Study Identification, Study Status, Oversight, Contacts/Locations v11
Start dateestimated 2025-03-23→confirmed 2025-02-24
Study sitesdetails revised at 3 of 15 sites
2025-02-06
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v10
Trial statusNot Yet Recruiting→Recruiting
Start date2024-12-23→2025-03-23
Study sitesdetails revised at 15 of 15 sites
2024-12-17
Study Status, Outcome Measures v9
Secondary endpointsdetails revised at 2 of 16 entries
2024-12-06
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v8
Primary completion date2025-03-01→2026-01
Completion date2025-03-01→2026-01
Start date2024-10-23→2024-12-23
Enrollment target70→100
Study sites1→15
Eligibility criteria-214 characters
Inclusion Criteria: PaediatricAdult participantspatients, agedand 6-17minor patients ≥ 2 years, old diagnosed with LGS, DS or DSTSC. Clinical decision, taken by the physician, to initiate Epidyolex® AvailabilityAdult ofparticipants, a diary with the number and type of epileptic seizures that occurred at least 28 days before the start of the study Parentsparents or legal representatives must be willing and able to give i [...] abstain from these products for the duration of the study. This study will not include participants who have already been prescribed Epidyolex® before the start of the study. A [...]
Secondary endpoints26 to 16 entries
Percentage Change from Baseline in Frequency of LGS/DS Associated Seizures (average per 28 days) Percentage Change from Baseline in Total Seizure Frequency (average per 28 days) Percentage of Participants Achieving a ≥25% Reduction in Seizure Frequency from Baseline Percentage of Participants Achiev [...] Change from Baseline to Week 5652 (V5) in the Child Behavior Check List (CBCL) Change from Baseline to Week 28 (V3) in the SleepVisual DisturbanceAnalog Scale for(VAS) Childrenof 10 Non-seizure Related Outcomes (SDSCNSRO) Change from Baseline to Week 5652 (V5) in the Sleep Disturbance Scale for Chil [...] [...]
Primary endpoints1 entry, revised
Change from Baseline to Study Visit in ProportionNumber of Participants Remaining on Therapy from Enrollment
Study description-28 characters
This observational study evaluates a Real-World population of children and adolescentadult participants affected by LGS, DS, and DSTSC and the effect of therapy with Epidyolex® administered acco [...] ptoms. The study will assess specific scales, questionnaires, the QoL of the participants, and the satisfaction of the caregivers and the participants/tutors.
Study title+28 characters
Epidyolex® in Lennox Gastaut and, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
2024-08-05
Study Identification, Study Status, Sponsor/Collaborators v7
Start date2024-06-23→2024-10-23
Collaborators+23 characters
Advice Pharma Group srl
2024-03-18
Study Identification, Study Status v6
Start date2024-03-01→2024-06-23
2024-02-21
Study Status v5
Re-verified, no change to tracked fields
2023-10-17
Study Status, Sponsor/Collaborators v4
Primary completion date2023-10→2025-03-01
Completion date2023-10→2025-03-01
Start date2023-04→2024-03-01
Collaborators-15 characters
Evidilya S.r.l.
2023-02-15
Study Status v3
Start date2023-01→2023-04
2022-12-01
Study Status v2
Start date2022-11→2023-01
2022-10-07
Study Status v1
Start date2022-09→2022-11
2022-08-01
Original filing
Jazz Pharmaceuticals
34 trials monitored
See 1 trial at risk
Epilepsy
723 trials monitored
See 41 trials at risk
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.
Trial Details
NCT Number NCT05485831
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Advice Pharma Group srl
Conditions Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
Enrollment 111 participants
Start Date 2025-02-24
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-03