Monitoring pregnancy outcomes for patients using Epidiolex during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the health outcomes related to pregnancy in women who have been exposed to Epidiolex or Epidyolex. It will track maternal complications, pregnancy complications, and birth outcomes, as well as monitor the health of infants up to 12 months of age. Participants must have received at least one dose of Epidiolex during the specified time frame. The study will gather data to better understand the implications of Epidiolex exposure during pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• United Biosource LLC
  Morgantown, West Virginia, United States Recruiting
• Vivantes Humboldt-Klinikum Klinik für Neurologie
  Berlin, Germany Recruiting
• JZP047-102 Research Summary for UK IRAS application
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.