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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113237
• Other study ID #: GWEP21095
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: August 31, 2033

Study information

• Verified date: May 2024
• Source: Jazz Pharmaceuticals
• Contact: Clinical Trial Disclosure & Transparency
• Phone: 215-832-3750
• Email: ClinicalTrialDisclosure[@]JazzPharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2033
• Est. primary completion date: August 31, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy
• Pregnancy Complication
• Pregnancy Complications

Intervention

Drug:
• Epidiolex
Oral solution

Locations

Country	Name	City	State
United States	United Biosource LLC	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MCM	Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age	Up to 12 months post birth
Secondary	Rate of pregnancy outcomes	Rate of the following pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth; Molar or ectopic pregnancy; Preterm delivery; Live birth	Up to 10 months gestation
Secondary	Rate of other events of interest in the developing neonate and infant	Rate of the following other events of interest in the developing neonate and infant: Hospitalizations for serious illness; Medications; Growth and development milestones; Neonatal or infant mortality; Inherited epilepsy syndrome	Up to 12 months post birth
Secondary	Rate of maternal complications during pregnancy	Rate of the following maternal complications during pregnancy: Premature rupture of membranes (PROM); Pre-eclampsia; Severe pregnancy-induced hypertension; Proteinuria; Gestational diabetes; Intrauterine growth restriction (IUGR); Measures of fetal growth deficiency (small for gestational age)	Up to 10 months gestation