Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting

GWEP20125

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.

2023-04-17

2025-03-01

2025-03-01

Recruiting

150

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-02-29