Status: Finalised First registered on: 16/05/2017
Last updated on: 15/10/2018
1. Study identification
EU PAS Register NumberEUPAS19129
Official titleUtilisation of antiepileptic medicines in girls and women of childbearing potential - a study in three European countries
Study title acronym
Study typeObservational study
Brief description of the studyThe use of certain antiepileptic drugs (AEDs) is known to increase the risk of both physical and neurodevelopmental abnormalities in the foetus and child. The European Medicines Agency recently carried out a review of the evidence relating to the use of the AED sodium valproate during pregnancy. Following this review, the guidelines for prescribing sodium valproate to women of childbearing age were changed in January 2015. This study will use electronic healthcare data from databases in the United Kingdom, France and Italy (Tuscany and Emilia Romagna). The study will calculate the prevalence of AED prescribing in all females of childbearing age and in females during pregnancy, stratified by calendar year, age at prescription and indication for prescribing. It will also look at the incidence of prescribing of each of the different AEDs among new users stratified by calendar year, age at prescription and indication for prescribing and evaluate the extent to which women switch AED products, particularly in relation to pregnancy.
Was this study requested by a regulator?Yes: EMA
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 belongsUniversity of Bath
Department/Research groupPharmacy & Pharmacology
Organisation/affiliationUniversity of Bath
Website/Homepagewww.bath.ac.uk
Details of (Primary) lead investigator
Title Dr
Last name Rachel
First name Charlton
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

University of Bath
ARS
Pharmacoepidemiology INSERM 1027
Centre for Environmental and Preventive Medicine, Queen Mary University of London, United Kingdom
Drug Policy Service, Emilia Romagna Region Health Authority, Italy
Countries in which this study is being conducted
International study

France
Italy
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/12/201616/12/2016
Start date of data collection09/05/201724/05/2017
Start date of data analysis09/09/201709/09/2017
Date of interim report, if expected04/05/2018
Date of final study report09/05/201807/06/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEuropean Medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rachel
First name Charlton
Address line 1Dept. of Pharmacy & Pharmacology
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom
Phone number (incl. country code)44-1225-383672 
Alternative phone number 
Fax number (incl. country code)44-1225-386114 
Email address r.a.charlton@bath.ac.uk
Public Enquiries
Title Dr 
Last name Rachel 
First name Charlton 
Address line 1Dept. of Pharmacy & Pharmacology 
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom 
Phone number (incl. country code)44-1225-383672 
Alternative phone number 
Fax number (incl. country code)44-1225-386114 
Email address r.a.charlton@bath.ac.uk 
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