UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
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Purpose
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).
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
- The number of birth defects reported and confirmed by a teratologist [ Time Frame: Throughout pregnancy and up to 3 years of life ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 516 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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AED treatment
Women being treated with UCB AEDs while pregnant.
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Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
See Inclusion Criteria
- Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant
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)
Contacts and Locations| Contact: Susan King-Zeller, RN, BSN, BSPH | 888-537-7734 | registries@kendle.com |
| Contact: James Zackheim, PhD | 770-970-8268 | james.zackheim@ucb.com |
| United States, North Carolina | |
| Kendle International, Inc. | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Contact: Susan King-Zeller, RN, BSN, BSPH 888-537-7734 registries@kendle.com | |
| Contact: James Zackheim, PhD 770-970-8268 james.zackheim@ucb.com | |
| Principal Investigator: | Vikki Brown, MD | INC Research |
| Study Director: | James Zackheim, PhD | UCB, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00345475 History of Changes |
| Other Study ID Numbers: | N01326 |
| Study First Received: | June 26, 2006 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UCB, Inc.:
|
Birth Defects Epilepsy High Risk Pregnancy |
Additional relevant MeSH terms:
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Congenital Abnormalities Epilepsy Pregnancy Complications Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013