RecruitingNCT06113237
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
Sponsor
Jazz Pharmaceuticals
Enrollment
50 participants
Start Date
Aug 5, 2025
Study Type
OBSERVATIONAL
Conditions
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
Sex: FEMALE
Inclusion Criteria2
- 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
Exclusion Criteria1
- \) 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.
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Interventions
DRUGEpidiolex
Oral solution
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06113237
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