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Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting

Study acronym: OPERA
StatusActive, Not Recruiting
PhaseNot specified
Started2023-04-17
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 15, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-06-11
Study Status v7
Re-verified, no change to tracked fields
2025-04-10
Completed→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusCompleted→Active, Not Recruiting
Primary completion date2024-07-15→2026-07
Completion date2024-07-15→2026-07
Study sites31→29
2024-08-14
Recruiting→Completed Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Completed
Primary completion dateestimated 2025-03-01→confirmed 2024-07-15
Completion dateestimated 2025-03-01→confirmed 2024-07-15
Enrollment targetestimated 150→confirmed 158
Study sitesdetails revised at 31 of 31 sites
2024-02-27
Study Status, Contacts/Locations v4
Primary completion date2025-03→2025-03-01
Completion date2025-03→2025-03-01
Study sites32→31
2023-07-25
Study Status, Contacts/Locations v3
Study sitesdetails revised at 9 of 32 sites
Show 2 earlier versions
2023-06-15
Study Status, Contacts/Locations v2
Study sites21→32
2023-05-15
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2023-04-17
Secondary endpointsdetails revised at 2 of 16 entries
Primary endpoints1 entry, revised
Retention RatesRate Percentage After Initiation of Treatment With Epidyolex
Study sitesdetails revised at 21 of 21 sites
2023-03-06
Original filing
Jazz Pharmaceuticals
34 trials monitored
See 1 trial at risk
Epilepsy
723 trials monitored
See 41 trials at risk
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.
Trial Details
NCT Number NCT05772429
Lead Sponsor Jazz Pharmaceuticals
Conditions Seizures
Enrollment 158 participants
Start Date 2023-04-17
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-15