NCT06113237Recruiting
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Jazz Pharmaceuticals
Start Date
8/5/2025
Completion Date
8/31/2033
Summary
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.
Eligibility Criteria
Age Range: No minimum to No maximum
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.
Interventions
DRUG
Epidiolex
Conditions
Maternal ComplicationsPregnancy ComplicationBirth Outcomes, AdversePregnancy
Locations
United Biosource LLC
Morgantown, West Virginia 26508
United States
Vivantes Humboldt-Klinikum Klinik für Neurologie
Berlin, 13509
Germany