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

Last updated: April 2, 2025
Sponsor: Jazz Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Pregnancy

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 priorto their LMP or during the pregnancy.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Epidiolex
Phase:
Study Start date:
July 30, 2025
Estimated Completion Date:
August 31, 2033

Connect with a study center

  • United Biosource LLC

    Morgantown, West Virginia 26508
    United States

    Active - Recruiting

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