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CBD epilepsy drug under Real-World watch for rare seizure disorders

NCT ID NCT05485831

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows about 111 people with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex who are taking Epidyolex (a CBD oral solution) for seizures. Researchers track how many stay on the drug for a year and how many seizure-free days they have. It's an observational study, meaning doctors prescribe the drug as usual, and no new treatment is being tested.

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, CBD) oral solution
What this could lead to
If successful, this could confirm that CBD helps control seizures in these hard-to-treat epilepsy syndromes, offering a real-world treatment option.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only follows patients for 52 weeks, and CBD may not work for everyone or may cause side effects.

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

111 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Feb 2027

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

The study will comprise of 70-100 male and female participants, aged ≥ 2 years, diagnosed with LGS, DS, and TSC. The decision to prescribe Epidyolex® as adjunctive therapy for seizures associated with LGS, DS, and TSC will be entirely independent of including the participant in the study.

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.

Inclusion Criteria: * Adult patients, and minor patients ≥ 2 years old diagnosed with LGS, DS or TSC. * Clinical decision, taken by the physician, to initiate Epidyolex® * Adult participants, parents or legal representatives must be willing and able to give informed consent/assent for participation in the study. Exclusion Criteria: * Participants currently using or have used recreational, medicinal cannabis, or cannabinoid-based products within the three months prior to study entry and are unwilling to abstain from these products for the duration of the study. * Any reason, according to Investigator's judgment, able to compromise compliance with procedures outlined in the study There will not be any other specific exclusion criteria; however, contraindications, special warnings, and precautions for use as detailed in the Summary of Product Characteristics (SmPC) (particularly related to raising of aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin) will have to be considered by the treating physician.

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic Lennox-Gastaut syndrome tuberous sclerosis tuberous sclerosis 1 visual epilepsy

As listed by the trial registrant

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

Dravet syndrome Lennox Gastaut syndrome Tuberous sclerosis complex

Contacts and locations

Locations

  • AOU Città della Salute PO Molinette

    Torino, 10126, Italy

  • AOU Gaetano Martino

    Messina, 98124, Italy

  • AOU Maggiore della Carità di Novara

    Novara, 28100, Italy

  • AOU di Padova

    Padova, 35128, Italy

  • ASST Grande Ospedale metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Meyer Neurologia Pediatrica

    Florence, 50139, Italy

  • Azienda Ospedaliero Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Azienda Ospedaliero Universitaria delle Marche

    Torrette, 60126, Italy

  • Centro Regionale Epilessia - ASST Santi Paolo e Carlo

    Milan, 20142, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli - IRCCS-NPI

    Roma, 00168, Italy

  • IRCCS Ospedale Pediatrico Bambin Gesù

    Roma, 00165, Italy

  • Istituto Gaslini Neurologia Pediatrica e Malattie Muscolari

    Genova, 16147, Italy

  • NPI AOU Mater Domini Università Magna Graecia

    Catanzaro, 88100, Italy

  • Ospedale Casa del sollievo e della sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Policlinico Sant'Orsola di Bologna

    Bologna, 40138, Italy

  • Policlinico Tor Vergata

    Roma, 00133, Italy

  • Università degli studi "G. D'annunzio" Chieti

    Chieti, 66100, Italy

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