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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06113237
Other study ID # GWEP21095
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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