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

Recruiting now

Conditions studied: Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy

In brief

The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.

Key facts

Study ID

NCT06113237

Run by

Jazz Pharmaceuticals

People needed

50

Starts

2025-08-05

Expected to finish

2033-08-31

Last updated by the study team

2026-07-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Verbal or written informed consent to participate

You may not qualify if…

• 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.

Where it is running

• United Biosource LLC — Morgantown, West Virginia, United States (enrolling)
• Vivantes Humboldt-Klinikum Klinik für Neurologie — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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