Clinical trial

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

Name

GWEP21095

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2033-08-31

Trial end

2033-08-31

Status

Recruiting

Treatment

Epidiolex

Oral solution

Arms:

Prospective Pregnancy, Retrospective Pregnancy

Other names:

Epidyolex, Cannabidiol

Size

Primary endpoint

Rate of MCM

Up to 12 months post birth

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-04-10

1 organization

1 product

5 indications

Product

Epidiolex

Indication

Maternal Complications

Indication

Complications of Pregnancy

Organization

Indication

Indication

Indication