Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00345475 · ClinicalTrials.gov registry record
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
A clinical trial, sponsored by UCB Pharma.
- Completed
- Registry status
- 516
- Enrollment target
NCT00345475: Completed study, sponsored by UCB Pharma.
NCT00345475 is a clinical trial that has completed, run by UCB Pharma. The registered enrollment target is 516 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00345475 has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- 516 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 516 participants |
| Start Date | 2004-12 |
| Est. Completion | 2016-05 |
What the finished NCT00345475 record still lists
NCT00345475 is an observational study that tracks outcomes without assigning an intervention. The registered 516 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00345475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00345475 about?
NCT00345475 is a clinical study titled "UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)". 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 Reg...
What is the current status of trial NCT00345475?
This trial is currently completed. The enrollment target is 516 participants. The study started on 2004-12. Estimated completion is 2016-05.
Who is sponsoring clinical trial NCT00345475?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05933083 · 516 participants · NA
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
- NCT05676450 · 517 participants · NA
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
- NCT05577819 · 515 participants · NA
Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
- NCT06804837 · 515 participants · NA
Implement and Test Visual Consent Template and Process
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia