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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345475
• Other study ID #: N01326
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2006
• Last updated: September 1, 2016
• Start date: December 2004
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Defects
• Congenital Abnormalities
• Epilepsy
• Pregnancy Complications
• Seizures

Locations

Country	Name	City	State
United States	INC Research	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of birth defects reported and confirmed by a teratologist	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.	Throughout pregnancy and up to 3 years of life	Yes

External Links

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