UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerl... | NCT00345475

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

NCT00345475

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Sep 2, 2016Estimated

Enrollment

516Actual

Phase

Not provided

Conditions

Birth Defects
Pregnancy Complications
Epilepsy
Seizures

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jun 26, 2006

First Submission Date that Met QC Criteria

Jun 26, 2006

First Posted Date

Jun 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2016

Last Update Posted Date

Sep 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

516Actual

Label	Type	Description	Intervention Names
AED treatment		Women being treated with UCB AEDs while pregnant.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

See Inclusion Criteria

- Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vikki Brown, MD	Syneos Health	Principal Investigator
Jürgen Bentz, PhD	UCB Pharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INC Research		Wilmington	North Carolina	28405	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31124321	Derived	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.

ID	Term
D000013	Congenital Abnormalities
D011248	Pregnancy Complications
D004827	Epilepsy
D012640	Seizures

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001927