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New study tracks epidiolex use in pregnancy for baby safety

NCT ID NCT06113237

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Updated 6 times

Summary

This study follows pregnant women who have taken Epidiolex (a cannabidiol medicine for seizures) to see if it affects pregnancy outcomes or the baby's health up to 12 months after birth. Researchers will track complications like birth defects, miscarriage, and preterm delivery. The goal is to better understand any risks, not to test a new treatment.

What this could mean

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

Active substance
Epidiolex (cannabidiol oral solution)
What this could lead to
If successful, this study could provide important safety information about using Epidiolex during pregnancy, helping doctors and patients make informed decisions.
What could go wrong
This is an observational study with only 50 participants, so results may not apply to everyone. It is designed to gather data, not to test a new treatment.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2033

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 who were exposed to at least one dose of Epidiolex/Epidyolex during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

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: 1. Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 days prior to their LMP or at any time during pregnancy. 2. Verbal or written informed consent to participate Exclusion criteria: 1\) Patients exposed to a non-regulatory approved product containing Cannabidiol (CBD) during pregnancy who do not also have exposure to Epidiolex during the 13 days prior to their LMP or during the pregnancy.

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Conditions

The condition(s) this trial relates to.

pregnancy disorder

As listed by the trial registrant

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

Birth outcomes, adverse Maternal complications Pregnancy Pregnancy complication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • United Biosource LLC

    RECRUITING

    Morgantown, West Virginia, 26508, United States

  • Vivantes Humboldt-Klinikum Klinik für Neurologie

    RECRUITING

    Berlin, 13509, Germany

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