Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorJazz Pharmaceuticals
About this trial
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
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Epidiolex
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
2Germany
Vivantes Humboldt-Klinikum Klinik für Neurologie13509, Berlin Germany
United States
United Biosource LLC26508, MorgantownWest Virginia, United States
Sponsors and collaborators
Jazz Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov