Status:
COMPLETED
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
Lead Sponsor:
UCB Pharma
Conditions:
Birth Defects
Pregnancy Complications
Eligibility:
FEMALE
Brief Summary
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The subjects must meet the following criteria for registration:
- Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
- Exposure to Keppra® and Keppra XR® on or after the first day of the patient's last menstrual period (verified by date or gestational age of exposure)
- For patient-initiated enrollments, provide verbal or written consent to participate in the Registry
- For patient-initiated enrollments, provide contact information for herself, her HCP, and the infant's HCP (as applicable)
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT00345475
Start Date
December 1 2004
End Date
May 1 2016
Last Update
September 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
INC Research
Wilmington, North Carolina, United States, 28405