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 from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra XR® in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population. The objectives of the UCB AED Pregnancy Registry are: – To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term pediatric outcome – To review reported cases of possible birth defects – To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra® and Keppra XR® during pregnancy This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).
Full Title of Study: “A Prospective Study Of Pregnancies Exposed to UCB Antiepileptic Drugs to Determine if There is a Potential Increase in the Risk of Major Birth Defects”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 2016
Arms, Groups and Cohorts
- AED treatment
- Women being treated with UCB AEDs while pregnant.
Clinical Trial Outcome Measures
- The number of birth defects reported and confirmed by a teratologist
- Time Frame: Throughout pregnancy and up to 3 years of life
- The purpose of the UCB AED Pregnancy Registry is to monitor pregnancies exposed to UCB AEDs to determine if there is a potential increase in the risk of major birth defects.
Participating in This Clinical Trial
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)
Gender Eligibility: Female
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- UCB Pharma
- Provider of Information About this Clinical Study
- Overall Official(s)
- Vikki Brown, MD, Principal Investigator, Syneos Health
- Jürgen Bentz, PhD, Study Director, UCB Pharma
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