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Real-World study tracks Epidyolex's Long-Term impact on seizures

NCT ID NCT05772429

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 158 people in France who are prescribed Epidyolex (a cannabidiol-based medicine) for seizures as part of their normal care. Researchers will track how long people stay on the treatment, side effects, seizure frequency, and changes in daily functioning and quality of life over two years. The goal is to understand how well Epidyolex works in real-world settings outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epidyolex (cannabidiol oral solution)
What this could lead to
If successful, this study could confirm how well Epidyolex works in everyday practice and help doctors better manage seizures long-term.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It does not test a new treatment, only monitors existing use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

158 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants for whom Epidyolex is prescribed according to the approved therapeutic indications and criteria of the summary of product Characteristics (SmPC). Participants will be recruited from approximately 15 facilities specializing in treating rare epilepsies in France.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • APHM - Marseille - service adulte

    Marseille, 13005, France

  • APHP Kremlin Bicetre - service enfant

    Le Kremlin-Bicêtre, 94270, France

  • APHP Necker - service enfant

    Paris, 75743, France

  • APHP Pitié Salpetriere- service adulte

    Paris, 75013, France

  • APHP Robert Debré - service enfant

    Paris, 75019, France

  • CHU Amiens-service adulte

    Amiens, 80054, France

  • CHU Amiens-service enfant

    Amiens, 80054, France

  • CHU Angers - service adulte

    Angers, 49100, France

  • CHU Angers - service enfant

    Angers, 49100, France

  • CHU Bordeaux - service adulte

    Bordeaux, 33000, France

  • CHU Bordeaux,neuropédiatrie

    Bordeaux, 33000, France

  • CHU Dijon - service neurophysiologie clinique

    Dijon, 21000, France

  • CHU Grenoble - service adulte

    Grenoble, 38700, France

  • CHU Grenoble - service enfant

    Grenoble, 38700, France

  • CHU Lille - service enfant

    Lille, 59037, France

  • CHU Nancy - service adulte

    Nancy, 54000, France

  • CHU Nancy - service enfant

    Nancy, 54000, France

  • CHU Rennes - service adulte

    Rennes, 35000, France

  • CHU Rennes - service enfant

    Rennes, 35200, France

  • CHU Strasbourg - service enfant

    Strasbourg, 67200, France

  • CHU Toulouse - service adulte

    Toulouse, 31059, France

  • CHU Toulouse - service enfant

    Toulouse, 31059, France

  • GH Est - Hôpital Femme Mère Enfant

    Bron, 69500, France

  • HCL - Lyon - service adulte

    Bron, 69677, France

  • Hôpital Bretonneau - service adulte

    Tours, 37000, France

  • Hôpital Clocheville - service enfant

    Tours, 37044, France

  • Hôpital Salengro - service adulte

    Lille, 59037, France

  • Hôpital de Hautepierre - service adulte

    Strasbourg, 67200, France

  • Hôpital de la Timone - service enfant

    Marseille, 13005, France

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