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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00345475
First received: June 26, 2006
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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 Phase
Birth Defects
Pregnancy Complications
Epilepsy
Seizures
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The number of birth defects reported and confirmed by a teratologist [ Time Frame: Throughout pregnancy and up to 3 years of life ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 516
Study Start Date: December 2004
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
AED treatment
Women being treated with UCB AEDs while pregnant.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345475

Locations
United States, North Carolina
INC Research
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
UCB Pharma
Investigators
Principal Investigator: Vikki Brown, MD INC Research
Study Director: Jürgen Bentz, PhD UCB Pharma
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00345475     History of Changes
Other Study ID Numbers: N01326
Study First Received: June 26, 2006
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UCB Pharma:
Birth Defects
Epilepsy
High Risk Pregnancy

Additional relevant MeSH terms:
Epilepsy
Pregnancy Complications
Congenital Abnormalities
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014