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

Jazz Pharmaceuticals

Status: Active, not recruiting

Conditions: Seizures

Treatments: Drug: Epidiolex

Study type: Observational

Funder types: Industry

Identifiers

NCT05772429

GWEP20125

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)).

Trial design

158 participants in 1 patient group

Epidyolex

Description:

Participants will receive Epidyolex in accordance with their routine clinical practice as prescribed by their physician.

Treatment:

Drug: Epidiolex