Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
OPERA
Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
1 other identifier
observational
158
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
April 13, 2025
April 1, 2025
3.2 years
March 6, 2023
April 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention Rate Percentage After Initiation of Treatment With Epidyolex
Retention rate will be measured through assessing the frequency of seizures and the length of time on treatment before a seizure event.
Up to 24 months post-dose.
Secondary Outcomes (16)
Percent Change From Baseline in Seizure Frequency (Average Per 28 Days)
Up to 24 months post-dose.
50% Responder Rate
Up to 24 months post-dose.
75% Responder Rate
Up to 24 months post-dose.
100% Responder (Seizure Freedom) Rate
Up to 24 months post-dose.
Number of Seizure-Free Days (Average Per 28 Days)
Up to 24 months post-dose.
- +11 more secondary outcomes
Study Arms (1)
Epidyolex
Participants will receive Epidyolex in accordance with their routine clinical practice as prescribed by their physician.
Interventions
Eligibility Criteria
Participants for whom Epidyolex is prescribed according to the approved therapeutic indications and criteria of the summary of product Characteristics (SmPC). Participants will be recruited from approximately 15 facilities specializing in treating rare epilepsies in France.
You may qualify if:
- Individuals for whom treatment with Epidyolex has been initiated by a physician with experience in the treatment of epilepsy.
- The participant and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study.
You may not qualify if:
- Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
CHU Amiens-service adulte
Amiens, 80054, France
CHU Amiens-service enfant
Amiens, 80054, France
CHU Angers - service adulte
Angers, 49100, France
CHU Angers - service enfant
Angers, 49100, France
CHU Bordeaux - service adulte
Bordeaux, 33000, France
CHU Bordeaux,neuropédiatrie
Bordeaux, 33000, France
GH Est - Hôpital Femme Mère Enfant
Bron, 69500, France
HCL - Lyon - service adulte
Bron, 69677, France
CHU Dijon - service neurophysiologie clinique
Dijon, 21000, France
CHU Grenoble - service adulte
Grenoble, 38700, France
CHU Grenoble - service enfant
Grenoble, 38700, France
APHP Kremlin Bicetre - service enfant
Le Kremlin-Bicêtre, 94270, France
CHU Lille - service enfant
Lille, 59037, France
Hôpital Salengro - service adulte
Lille, 59037, France
APHM - Marseille - service adulte
Marseille, 13005, France
Hôpital de la Timone - service enfant
Marseille, 13005, France
CHU Nancy - service adulte
Nancy, 54000, France
CHU Nancy - service enfant
Nancy, 54000, France
APHP Pitié Salpetriere- service adulte
Paris, 75013, France
APHP Robert Debré - service enfant
Paris, 75019, France
APHP Necker - service enfant
Paris, 75743, France
CHU Rennes - service adulte
Rennes, 35000, France
CHU Rennes - service enfant
Rennes, 35200, France
CHU Strasbourg - service enfant
Strasbourg, 67200, France
Hôpital de Hautepierre - service adulte
Strasbourg, 67200, France
CHU Toulouse - service adulte
Toulouse, 31059, France
CHU Toulouse - service enfant
Toulouse, 31059, France
Hôpital Bretonneau - service adulte
Tours, 37000, France
Hôpital Clocheville - service enfant
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 16, 2023
Study Start
April 17, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
April 13, 2025
Record last verified: 2025-04