Status: Finalised First registered on: 16/02/2015
Last updated on: 26/02/2019
1. Study identification
EU PAS Register NumberEUPAS8618
Official titleLamotrigine use in Pregnancy and Risk of Orofacial Clefts II
Study title acronym
Study typeOther: Case-malformed control study
Brief description of the studyFollowing a US Federal Drugs Agency alert in 2006 concerning an increased risk of orofacial cleft associated with first trimester exposure to the new anti-epileptic drug (AED) lamotrigine, the EUROCAT AED database was created in 2007 to evaluate this signal using EUROCAT data. The original database included data from 19 registries covering a population of 4 million births, 1995-2005. The database was used to conduct a case-control study evaluating the risk of orofacial clefts in relation to lamotrigine exposure. The study found no evidence of a specific increased risk of isolated orofacial clefts relative to other malformations due to lamotrigine monotherapy. In order to estimate the risk of orofacial clefts relative to other malformations more precisely and to explore whether lamotrigine exposure may be associated with other malformations, a follow-up study was commissioned. This involved 5 yearly updates (2009, 2010, 2011, 2012, and 2013). The final study included data from 21 registries and covered over 10 million births. No evidence of an increased risk of orofacial clefts relative to other malformations associated with lamotrigine exposure in the first trimester was found.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsMFIR-Ulster
Department/Research groupCentre for Maternal, Fetal and Infant Research
Organisation/affiliationUniversity of Ulster
Website/Homepagehttp://www.science.ulster.ac.uk/inr/mfir.php
Details of (Primary) lead investigator
Title Professor
Last name Dolk
First name Helen
Is this study being carried out with the collaboration of a research network?
Yes

EUROCAT
EUROmediCAT
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Belgium
Croatia
Denmark
Finland
France
Germany
Ireland
Italy
Malta
Netherlands
Norway
Portugal
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/05/2009
Start date of data collection17/08/2009
Start date of data analysis29/10/2009
Date of interim report, if expected
Date of final study report15/03/201515/03/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGSK50
Charities
Government body
Research councils
EU funding schemeDG Sanco50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Dolk
First name Helen
Address line 1Shore Rd
Address line 2 
Address line 3 
CityNewtownabbey 
PostcodeBT370QB 
CountryUnited Kingdom
Phone number (incl. country code)442890368540 
Alternative phone number 
Fax number (incl. country code)442890368341 
Email address h.dolk@ulster.ac.uk
Public Enquiries
Title Professor 
Last name Dolk 
First name Helen 
Address line 1Shore Rd 
Address line 2 
Address line 3 
CityNewtownabbey 
PostcodeBT370QB 
CountryUnited Kingdom 
Phone number (incl. country code)442890368540 
Alternative phone number 
Fax number (incl. country code)442890368341 
Email address h.dolk@ulster.ac.uk 
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