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Active Not RecruitingNCT05772429

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

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
158 (actual)
Sponsor
Jazz Pharmaceuticals · Industry
Sex
All
Age
2 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGEpidiolexAdministered as an oral solution

Timeline

Start date
2023-04-17
Primary completion
2026-07-01
Completion
2026-07-01
First posted
2023-03-16
Last updated
2025-04-13

Locations

29 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05772429. Inclusion in this directory is not an endorsement.