UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00345475 |
Recruitment Status
:
Completed
First Posted
: June 28, 2006
Last Update Posted
: September 2, 2016
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date | June 26, 2006 | ||||||
First Posted Date | June 28, 2006 | ||||||
Last Update Posted Date | September 2, 2016 | ||||||
Study Start Date | December 2004 | ||||||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||||||
Current 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 ] 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.
|
||||||
Original Primary Outcome Measures | Not Provided | ||||||
Change History | Complete list of historical versions of study NCT00345475 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Outcome Measures | Not Provided | ||||||
Original Other Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry) | ||||||
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 | ||||||
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:
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). |
||||||
Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Time Perspective: Prospective | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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 |
||||||
Condition |
|
||||||
Intervention | Not Provided | ||||||
Study Groups/Cohorts | AED treatment
Women being treated with UCB AEDs while pregnant. |
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
516 | ||||||
Original Enrollment |
300 | ||||||
Actual Study Completion Date | May 2016 | ||||||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria: The subjects must meet the following criteria for registration:
|
||||||
Sex/Gender |
|
||||||
Ages | Child, Adult, Senior | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00345475 | ||||||
Other Study ID Numbers | N01326 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | UCB Pharma | ||||||
Study Sponsor | UCB Pharma | ||||||
Collaborators | Not Provided | ||||||
Investigators |
|
||||||
PRS Account | UCB Pharma | ||||||
Verification Date | September 2016 |