Birth DefectsNCT00345475
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
An observational study of Birth Defects and Pregnancy Complications, run by UCB Pharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Birth Defects, Pregnancy Complications, Epilepsy
- How many people
- 516 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: See Inclusion Criteria - Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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).
- Conditions
- Birth Defects, Pregnancy Complications, Epilepsy, Seizures
- Keywords
- Birth Defects, Epilepsy, High Risk Pregnancy
- Medical subject headings
- Congenital Abnormalities, Pregnancy Complications, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AED treatment | Women being treated with UCB AEDs while pregnant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout pregnancy and up to 3 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startDec 2004
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikki Brown, MD, Principal investigator, Syneos HealthJürgen Bentz, PhD, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345475
- Sponsor's protocol ID
- N01326
- Status last verified
- Sep 2016
- First submitted
- 26 Jun 2006
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31124321
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00345475
- Acronym / sponsor ID
- N01326
- Conditions
- Birth Defects, Pregnancy Complications, Epilepsy, Seizures
- Keywords
- Birth Defects, Epilepsy, High Risk Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AED treatment | – | –Women being treated with UCB AEDs while pregnant. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- See Inclusion Criteria - Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Derived from this study: PubMed 31124321Scheuerle 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikki Brown, MD principal investigator
Syneos Health
Jürgen Bentz, PhD study director
UCB Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Defects and Pregnancy Complications, run by UCB Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of birth defects reported and confirmed by a teratologist (time frame: Throughout pregnancy and up to 3 years of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.