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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00345475

First received: June 26, 2006

Last updated: September 1, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 26, 2006

Last Updated Date

September 1, 2016

Start Date ^ICMJE

December 2004

Primary Completion Date

May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00345475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Birth Defects
Pregnancy Complications
Epilepsy
Seizures

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

516

Completion Date

May 2016

Primary Completion Date

May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00345475

Other Study ID Numbers ^ICMJE

N01326

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

UCB Pharma

Study Sponsor ^ICMJE

UCB Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Vikki Brown, MD	INC Research
Study Director:	Jürgen Bentz, PhD	UCB Pharma

PRS Account

UCB Pharma

Verification Date

September 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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