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Epidiolex liver check: is Long-Term use safe?

NCT ID NCT05044819

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 7 times

Summary

This study follows 154 people taking Epidiolex (cannabidiol) for seizures caused by Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. Researchers will monitor for signs of chronic liver injury and fibrosis over time using blood tests and liver scans. The goal is to understand the long-term liver safety of this medication.

What this could mean

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

Active substance
Cannabidiol (Epidiolex) oral solution
What this could lead to
If successful, this study could confirm that long-term use of Epidiolex is safe for the liver, reassuring patients and doctors.
What could go wrong
This is an observational safety study, not a test of effectiveness. It may find liver risks that limit use, and results may not apply to all patients.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

154 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Mar 2028

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.

Ages

1 year 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: * Participant is within the approved age range as per labeling recommendations. Participants aged 1 to 3 years who are in the FibroScan subset will not undergo FibroScan assessments until they reach 4 years of age. * Participant is either on existing Epidiolex therapy for treatment of a seizure disorder or is to be started on Epidiolex for treatment of an Food and Drug Administration (FDA)-approved indication. * Participant is willing to refrain from strenuous exercise 48 to 72 hours prior to all study visits with the exception of unscheduled visits. * Any non-pharmacological therapies (e.g., ketogenic diet) must also be stable up to 4 weeks prior to Screening Visit and expected to be stable throughout the duration of the study. Exclusion Criteria: * Participant is currently using or within 3 months of screening has used recreational or medicinal cannabis, or synthetic cannabinoid-based medications, not including Epidiolex if currently prescribed. * Participant is not planning to abstain from using recreational cannabinoids or medicinal cannabis, or synthetic cannabinoid-based medications during the study. * Female participant is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for 3 months thereafter. * Participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study * Participant has diseases or disorders which are associated with liver fibrosis with a FibroScan score of ≥ 6.5 Kilopascals (where FibroScan results are available). * Positive serology panel (including hepatitis B surface antigen and hepatitis C virus antibody) and/or positive human immunodeficiency virus antibody/p24 antigen screens at screening. * Following a physical examination, if the participant has any abnormalities that, in the opinion of the investigator, would prevent the participant from safe participation in the study. * Participant has significantly impaired hepatic function at Screening Visit alanine aminotransferase or aminotransferase \> 3 x upper limit of normal (ULN), and total bilirubin \> 2 x ULN or international normalized ratio \> 1.5. * Participant is planning to have epilepsy surgery or other major surgery within five years. * Participant has or plans to have any medical device implanted that is contraindicated for use with FibroScan (only applicable for FibroScan subset), with the investigator consulting with the Sponsor as needed. * Participation in any clinical trial involving an investigational medicinal product within 3 months prior to the Screening Visit or at any point during this study.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Dravet syndrome Epilepsies, Myoclonic Lennox-Gastaut syndrome tuberous sclerosis tuberous sclerosis 1

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

  • Clinical Trial Site

    Little Rock, Arkansas, 72758, United States

  • Clinical Trial Site

    Downey, California, 90242, United States

  • Clinical Trial Site

    Long Beach, California, 90806, United States

  • Clinical Trial Site

    Sacramento, California, 95817, United States

  • Clinical Trial Site

    Miami, Florida, 33136, United States

  • Clinical Trial Site

    Miami, Florida, 33176, United States

  • Clinical Trial Site

    Orlando, Florida, 32806, United States

  • Clinical Trial Site

    Tampa, Florida, 33606, United States

  • Clinical Trial Site

    Augusta, Georgia, 30912, United States

  • Clinical Trial Site

    Wichita, Kansas, 67214, United States

  • Clinical Trial Site

    Lexington, Kentucky, 40504, United States

  • Clinical Trial Site

    Baltimore, Maryland, 21205, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02114, United States

  • Clinical Trial Site

    New Brunswick, New Jersey, 08901, United States

  • Clinical Trial Site

    New York, New York, 10016, United States

  • Clinical Trial Site

    Charlotte, North Carolina, 28203, United States

  • Clinical Trial Site

    Durham, North Carolina, 27708, United States

  • Clinical Trial Site

    Cincinnati, Ohio, 45219, United States

  • Clinical Trial Site

    Oklahoma City, Oklahoma, 73104, United States

  • Clinical Trial Site

    Philadelphia, Pennsylvania, 19107, United States

  • Clinical Trial Site

    Charleston, South Carolina, 29425, United States

  • Clinical Trial Site

    Austin, Texas, 78758, United States

  • Clinical Trial Site

    Dallas, Texas, 75251, United States

  • Clinical Trial Site

    Houston, Texas, 77030, United States

  • Clinical Trial Site

    Round Rock, Texas, 78681, United States

  • Clinical Trial Site

    Winchester, Virginia, 22601, United States

More trials for these conditions

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