Status: Finalised First registered on: 16/02/2015
Last updated on: 16/02/2015
1. Study identification
EU PAS Register NumberEUPAS8615
Official titleLamotrigine use in Pregnancy and Risk of Orofacial Clefts
Study title acronym
Study typeOther: Case- malformed control study
Brief description of the studyA case-malformed control study evaluating the risk of orofacial clefts in relation to first trimester exposure to the the new anti-epileptic drug (AED) lamotrigine was conducted using data from 19 EUROCAT registries covering a population of 4 million births, 1995-2005. The study found no evidence of a specific increased risk of isolated orofacial clefts relative to other malformations due to lamotrigine monotherapy. This study was conducted following a US Federal Drugs Agency alert in 2006 concerning an increased risk of orofacial cleft associated with lamotrigine exposure.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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
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
France
Germany
Ireland
Italy
Malta
Netherlands
Norway
Poland
Spain
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/02/200707/02/2007
Start date of data collection15/02/2007
Start date of data analysis18/04/2007
Date of interim report, if expected
Date of final study report31/07/2007
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGSK100
Charities
Government body
Research councils
EU funding scheme
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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