Status:
RECRUITING
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Maternal Complications
Pregnancy Complication
Eligibility:
FEMALE
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 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.
Exclusion
Key Trial Info
Start Date :
August 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2033
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06113237
Start Date
August 5 2025
End Date
August 31 2033
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
United Biosource LLC
Morgantown, West Virginia, United States, 26508