RecruitingOBSERVATIONAL

Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy

This study, called a Pregnancy Surveillance Program, aims to understand what happens when pregnant women take a medicine called Epidiolex (also known as Epidyolex). This medicine is used to treat certain types of severe seizures. The researchers want to learn about the health of the mother during and after pregnancy, and the health and development of her baby for the first 12 months after birth. This is important to help doctors and patients understand the potential effects of this medication during pregnancy. By gathering this information, they hope to improve care for pregnant women who need to take this medicine.

At a glance

Status

Recruiting

Sponsor

Jazz Pharmaceuticals

Enrolment target

Start

05 Aug 2025

Estimated completion

31 Aug 2033

Maternal Complications Pregnancy Complication Birth Outcomes, Adverse Pregnancy

What is this study about?

This study is called a 'Pregnancy Surveillance Program.' This means it's like a careful watch or monitoring program. The main aim is to understand what happens to pregnant women and their babies if the mother has taken a medicine called Epidiolex (also known as Epidyolex). This medicine is used to treat specific types of severe seizures that don't get better with other treatments.

The researchers want to gather information about pregnancy-related health outcomes. This includes looking at any health issues the mother might experience during her pregnancy, any complications, and the baby's health and development. They will follow the baby's health up to 12 months (one year) after they are born. This type of study helps doctors understand how medications might affect pregnancy and babies over time.

Collecting this information is really important because it helps improve the advice and care given to pregnant women who might need to take Epidiolex. It also helps patients and their doctors make informed decisions about treatment during pregnancy, ensuring the best possible care for both mother and baby.

Key takeaways

This study tracks pregnant women who took Epidiolex and their babies.
It aims to learn about health outcomes during pregnancy and for the baby's first year.
Participation helps future mothers and doctors make informed decisions.
You would share health information, not receive new treatments.
Your baby's health is monitored for 12 months after birth.

Who may be eligible?

To be part of this study, you need to be a woman who has become pregnant and has taken at least one dose of Epidiolex (or Epidyolex). This includes if you took it within 13 days before your last period, or at any point during your pregnancy.

Before you can join, you'll need to give your permission to take part, either by speaking with the study team or signing a form.

You won't be able to join this particular study if you only took other CBD products (cannabidiol) that are not Epidiolex and were not approved for medical use, and did not take Epidiolex itself during pregnancy or just before.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am currently pregnant or have recently been pregnant.
I took Epidiolex (or Epidyolex) at some point around or during my pregnancy.
I am willing to provide information about my health and my baby's health.
I understand that I am not receiving new medication through this study.

Answer every question to see your result.

What does participation involve?

This study is a surveillance program, meaning it largely involves sharing information rather than receiving new treatments. You would probably be asked to share information about your health during pregnancy and your baby's health after birth. This might involve your doctors providing medical records, or you completing questionnaires. There are no specific visits to a study clinic being described here, nor will you be given any study medication; the study is observing those who have already taken Epidiolex as part of their standard medical care. The follow-up for your baby will last until they are 12 months old.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers learn more about how Epidiolex affects pregnancy and babies. This information can help other pregnant women and their doctors make better decisions in the future. Since this is an observational study and you are not being given new medication, there are no specific medical risks from participation itself. Your healthcare as usual will continue. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

United Biosource LLC
Verified postcode
Morgantown, United States· Recruiting
Vivantes Humboldt-Klinikum Klinik für Neurologie
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is Epidiolex?

Epidiolex is a medicine used to treat certain types of severe seizures.

Why is this study being done?

It's being done to understand how taking Epidiolex during pregnancy affects the mother and her baby.

Does this study involve taking new medicine?

No, this study is for people who have already taken Epidiolex as part of their usual treatment.

How long will my baby be followed?

Your baby will be followed until they are 12 months old.

Will my privacy be protected if I join?

Yes, all studies have strict rules to protect your personal and medical information.

How to find out more

Clinical Trial Disclosure & Transparency

clinicaltrialdisclosure@jazzpharma.com 215-832-3750 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.