Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345475
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2006-06-26
Brief Title:
UCB Antiepileptic Drugs AED Pregnancy Registry Formerly the Keppra Pregnancy Registry
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie any time from the first day of the last menstrual period andor 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 teratologygenetics epidemiology maternal and fetal medicine and neurology external member details available upon request
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 teratologygenetics epidemiology maternal and fetal medicine and neurology external member details available upon request
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None