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

Jazz Pharmaceuticals

Status: Enrolling

Conditions: Birth Outcomes, Adverse; Pregnancy Complication; Maternal Complications; Pregnancy

Treatments: Drug: Epidiolex

Study type: Observational

Funder types: Industry

Identifiers

NCT06113237

GWEP21095

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Retrospective Pregnancy

Description:

Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.

Treatment:

Drug: Epidiolex

Prospective Pregnancy

Description:

Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.

Treatment:

Drug: Epidiolex