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

NCT ID: NCT05772429

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-17

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epidyolex

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

Epidiolex

Intervention Type DRUG

Administered as an oral solution

Interventions

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Epidiolex

Administered as an oral solution

Intervention Type DRUG

Other Intervention Names

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Cannabidiol Epidyolex

Eligibility Criteria

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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.

Exclusion Criteria

* Previously initiated with Epidyolex before the start of the study (especially during the French early access program (EAP)).
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens-service adulte

Amiens, , France

Site Status

CHU Amiens-service enfant

Amiens, , France

Site Status

CHU Angers - service adulte

Angers, , France

Site Status

CHU Angers - service enfant

Angers, , France

Site Status

CHU Bordeaux - service adulte

Bordeaux, , France

Site Status

CHU Bordeaux,neuropédiatrie

Bordeaux, , France

Site Status

GH Est - Hôpital Femme Mère Enfant

Bron, , France

Site Status

HCL - Lyon - service adulte

Bron, , France

Site Status

CHU Dijon - service neurophysiologie clinique

Dijon, , France

Site Status

CHU Grenoble - service adulte

Grenoble, , France

Site Status

CHU Grenoble - service enfant

Grenoble, , France

Site Status

APHP Kremlin Bicetre - service enfant

Le Kremlin-Bicêtre, , France

Site Status

CHU Lille - service enfant

Lille, , France

Site Status

Hôpital Salengro - service adulte

Lille, , France

Site Status

APHM - Marseille - service adulte

Marseille, , France

Site Status

Hôpital de la Timone - service enfant

Marseille, , France

Site Status

CHU Nancy - service adulte

Nancy, , France

Site Status

CHU Nancy - service enfant

Nancy, , France

Site Status

APHP Pitié Salpetriere- service adulte

Paris, , France

Site Status

APHP Robert Debré - service enfant

Paris, , France

Site Status

APHP Necker - service enfant

Paris, , France

Site Status

CHU Rennes - service adulte

Rennes, , France

Site Status

CHU Rennes - service enfant

Rennes, , France

Site Status

CHU Strasbourg - service enfant

Strasbourg, , France

Site Status

Hôpital de Hautepierre - service adulte

Strasbourg, , France

Site Status

CHU Toulouse - service adulte

Toulouse, , France

Site Status

CHU Toulouse - service enfant

Toulouse, , France

Site Status

Hôpital Bretonneau - service adulte

Tours, , France

Site Status

Hôpital Clocheville - service enfant

Tours, , France

Site Status

Countries

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France

Other Identifiers

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GWEP20125

Identifier Type: -

Identifier Source: org_study_id

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