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

Last updated: February 23, 2026
Sponsor: Jazz Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Pregnancy Complications

Treatment

Epidiolex

Clinical Study ID

NCT06113237
GWEP21095
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 daysprior to their LMP or at any time during pregnancy.

  2. Verbal or written informed consent to participate

Exclusion

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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Epidiolex
Phase:
Study Start date:
August 05, 2025
Estimated Completion Date:
August 31, 2033

Connect with a study center

  • United Biosource LLC

    Morgantown, West Virginia 26508
    United States

    Site Not Available

  • United Biosource LLC

    Morgantown 4815352, West Virginia 4826850 26508
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.