Recruiting

Epidiolex/Epidyolex

Sponsor:

Jazz Pharmaceuticals

Code:

NCT06113237

Conditions

Maternal Complications

Pregnancy Complication

Birth Outcomes, Adverse

Pregnancy

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Epidiolex

Study Details

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

Study ID

NCT06113237

Start date

Aug 5, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2033

Anticipated

Primary completion date

Aug 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Epidiolex

Oral solution

Primary outcome measure

  • Rate of MCM [ Time Frame: Up to 12 months post birth ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure & Transparency

215-832-3750ClinicalTrialDisclosure@JazzPharma.com

Locations

United Biosource LLC

Recruiting

Morgantown, West Virginia, United States, 26508

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Epidiolex
  • Epidyolex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2026-08-20.