Clinical Trial

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

Study acronym: OPERA
Active, Not Recruiting
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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.
Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-03-06; most recent amendment 2026-06-11.
Status change: Completed → Active, Not Recruiting 2025-04-10
Status change: Recruiting → Completed 2024-08-14
Status change: Not Yet Recruiting → Recruiting 2023-05-15
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