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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

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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