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Clinical Trials in France / NCT05772429
Active, not recruiting Observational

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

NCT05772429 · tracked via the Priya Life Science France tracker
Sponsor
Jazz Pharmaceuticals
Phase
Observational
Started
2023-04-17
Last updated
2026-06-15

Condition(s) studied

Seizures

Investigational drug(s) / intervention(s)

Epidiolex →

Epidiolex: Administered as an oral solution

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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)).

Primary outcome measure(s)

  • Retention Rate Percentage After Initiation of Treatment With Epidyolex — Up to 24 months post-dose.
    Retention rate will be measured through assessing the frequency of seizures and the length of time on treatment before a seizure event.

Trial sites (29)

FacilityCityRegionStatus
CHU Amiens-service adulte Amiens France
CHU Amiens-service enfant Amiens France
CHU Angers - service adulte Angers France
CHU Angers - service enfant Angers France
CHU Bordeaux - service adulte Bordeaux France
CHU Bordeaux,neuropédiatrie Bordeaux France
GH Est - Hôpital Femme Mère Enfant Bron France
HCL - Lyon - service adulte Bron France
CHU Dijon - service neurophysiologie clinique Dijon France
CHU Grenoble - service adulte Grenoble France
CHU Grenoble - service enfant Grenoble France
APHP Kremlin Bicetre - service enfant Le Kremlin-Bicêtre France
CHU Lille - service enfant Lille France
Hôpital Salengro - service adulte Lille France
APHM - Marseille - service adulte Marseille France
Hôpital de la Timone - service enfant Marseille France
CHU Nancy - service adulte Nancy France
CHU Nancy - service enfant Nancy France
APHP Pitié Salpetriere- service adulte Paris France
APHP Robert Debré - service enfant Paris France
APHP Necker - service enfant Paris France
CHU Rennes - service adulte Rennes France
CHU Rennes - service enfant Rennes France
CHU Strasbourg - service enfant Strasbourg France
Hôpital de Hautepierre - service adulte Strasbourg France
CHU Toulouse - service adulte Toulouse France
CHU Toulouse - service enfant Toulouse France
Hôpital Bretonneau - service adulte Tours France
Hôpital Clocheville - service enfant Tours France

More Jazz Pharmaceuticals trials in France

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Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Recruiting
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05772429 on ClinicalTrials.gov ↗ ← All trials in France