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

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ClinicalTrials.gov Identifier: NCT00345475
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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).


Condition or disease
Birth Defects Pregnancy Complications Epilepsy Seizures

Study Design
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Study Type : Observational
Actual Enrollment : 516 participants
Time Perspective: Prospective
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
Study Start Date : December 2004
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
AED treatment
Women being treated with UCB AEDs while pregnant.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345475


Locations
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United States, North Carolina
INC Research
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
UCB Pharma
Investigators
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Principal Investigator: Vikki Brown, MD Syneos Health
Study Director: Jürgen Bentz, PhD UCB Pharma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00345475    
Other Study ID Numbers: N01326
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Keywords provided by UCB Pharma:
Birth Defects
Epilepsy
High Risk Pregnancy
Additional relevant MeSH terms:
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Epilepsy
Seizures
Pregnancy Complications
Congenital Abnormalities
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations