Monitoring pregnancy outcomes for patients using Epidiolex during pregnancy
Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
This study looks at how using Epidiolex during pregnancy affects the health of mothers and their babies to see what outcomes they experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | Female |
| Sponsor | Jazz Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT06113237 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who have been exposed to Epidiolex or Epidyolex during their pregnancy.
Not a fit: Patients who have used non-regulatory approved products containing CBD without exposure to Epidiolex will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of Epidiolex use during pregnancy, potentially guiding treatment decisions for expectant mothers.
How similar studies have performed: While there may be limited data on similar studies, this approach is relatively novel in the context of monitoring pregnancy outcomes specifically related to Epidiolex exposure.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Morgantown, West Virginia
- United Biosource LLC — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Disclosure & Transparency
- Email: ClinicalTrialDisclosure@JazzPharma.com
- Phone: 215-832-3750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.