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

NCT06113237 | Recruiting

• 1 other identifier: GWEP21095
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Epidiolex; Epidyolex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of pregnancy outcomes

  Up to 10 months gestation

• Rate of other events of interest in the developing neonate and infant

  Up to 12 months post birth

• Rate of maternal complications during pregnancy

  Up to 10 months gestation

Study Arms (2)

Retrospective Pregnancy

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.

Drug: Epidiolex

Prospective Pregnancy

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.

Drug: Epidiolex

Interventions

Epidiolex DRUG

Oral solution

Also known as: Epidyolex, Cannabidiol

Prospective Pregnancy; Retrospective Pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants who were exposed to at least one dose of Epidiolex/Epidyolex during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy.

You may qualify if:

• 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.
• Verbal or written informed consent to participate

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

United Biosource LLC

Morgantown, West Virginia, 26508, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 31, 2033
• Study Completion (Estimated): August 31, 2033
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)