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

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT06113237
Status
Recruiting
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Conditions

  • Birth Outcomes, Adverse
  • Maternal Complications
  • Pregnancy
  • Pregnancy Complication

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epidiolex — DRUG
    Oral solution

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
May 2026
Primary completion
Aug 31, 2033
Completion
Aug 31, 2033

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Retrospective Pregnancy
    Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.
  • Arm: Prospective Pregnancy
    Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.

Primary Outcome Measure

Rate of MCM [ Time Frame: Up to 12 months post birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
United Biosource LLCMorgantownWest Virginia26508-

Find similar trials in Morgantown, WV

By research site
United Biosource LLC· Morgantown, WV

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