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

NCT00345475 | Completed DMC

• 1 other identifier: N01326
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 1

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).

Conditions

Birth Defects; Pregnancy Complications; Epilepsy; Seizures

Keywords

Birth Defects; Epilepsy; High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AED treatment

Women being treated with UCB AEDs while pregnant.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

INC Research

Wilmington, North Carolina, 28405, United States

Location

Related Publications (1)

• Scheuerle AE, Holmes LB, Albano JD, Badalamenti V, Battino D, Covington D, Harden C, Miller D, Montouris GD, Pantaleoni C, Thorp J, Tofighy A, Tomson T, Golembesky AK. Levetiracetam Pregnancy Registry: Final results and a review of the impact of registry methodology and definitions on the prevalence of major congenital malformations. Birth Defects Res. 2019 Aug 1;111(13):872-887. doi: 10.1002/bdr2.1526. Epub 2019 May 23.

  PMID: 31124321 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Congenital Abnormalities; Pregnancy Complications; Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vikki Brown, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

• Jürgen Bentz, PhD

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2006
• First Posted: June 28, 2006
• Study Start: December 1, 2004
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-09

Locations

US (1)