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Clinical Trials in Italy / NCT06113237
Recruiting Observational

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

NCT06113237 · tracked via the Priya Life Science Italy tracker
Sponsor
Jazz Pharmaceuticals
Phase
Observational
Started
2025-08-05
Last updated
2026-10-02

Condition(s) studied

Maternal ComplicationsPregnancy ComplicationBirth Outcomes, AdversePregnancy

Investigational drug(s) / intervention(s)

Epidiolex →

Epidiolex: Oral solution

Study 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

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of MCM — Up to 12 months post birth
    Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age

Trial sites (3)

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

More Jazz Pharmaceuticals trials in Italy

Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY Active, not recruiting
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) Recruiting
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer Recruiting
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Recruiting
A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Recruiting

Other trials for the same condition

Maternal Risk, Fetal-Neonatal Brain Connectivity, and Early Neurodevelopment: A Longitudinal Observational Study Enrolling by invitation
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Recruiting
Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy Recruiting
Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination Recruiting
Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06113237 on ClinicalTrials.gov ↗ ← All trials in Italy