UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)

Tracking Information
First Submitted Date	June 26, 2006
First Posted Date	June 28, 2006
Last Update Posted Date	September 2, 2016
Study Start Date	December 2004
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 14, 2013)	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.
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00345475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
Official Title	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
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 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).
Detailed Description	Not Provided
Study Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	See Inclusion Criteria - Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant
Condition	Birth Defects; Pregnancy Complications; Epilepsy; Seizures
Intervention	Not Provided
Study Groups/Cohorts	AED treatment; Women being treated with UCB AEDs while pregnant.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: January 14, 2013)	516
Original Enrollment; (submitted: June 26, 2006)	300
Actual Study Completion Date	May 2016
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria	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)
Sex/Gender	Sexes Eligible for Study: Female
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00345475
Other Study ID Numbers	N01326
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	UCB Pharma
Study Sponsor	UCB Pharma
Collaborators	Not Provided
Investigators	Principal Investigator: Vikki Brown, MD INC Research Study Director: Jürgen Bentz, PhD UCB Pharma
PRS Account	UCB Pharma
Verification Date	September 2016