Status: Planned First registered on: 30/09/2020
Last updated on: 30/09/2020
1. Study identification
EU PAS Register NumberEUPAS37438
Official titleNon-Interventional retrospective longitudinal study in the UK and France to evaluate and identify the best practices for switching of valproate and related substances in clinical practice
Study title acronymVALSE study - VALNAC09344
Study typeObservational study
Brief description of the studyIn Europe, valproate and related substances have been licensed to treat epilepsy and bipolar disorder. Following the identification of an increased risk of malformations and neurodevelopmental disorders in children exposed to valproate in utero, in 2018 the Pharmacovigilance Risk Assessment Committee (PRAC) recommended restrictions on the use of valproate for the treatment of woman of child-bearing potential (WCBP) and pregnant woman. Recommendations on switching or discontinuation of valproate remained poorly defined. The PRAC requested the consortium of Marketed Authorization Holders to conduct an observational study aimed to evaluate and identify the best practices for switching of valproate in clinical practice. The primary study objective is (i) to identify treatment patterns of switching or discontinuation of valproate associated with a successful switch after valproate discontinuation in valproate WCBP chronic users and in a subpopulation of pregnant women, (ii) to identify patients’ or disease characteristics associated with a successful switch after valproate discontinuation in valproate WCBP chronic users and in a subpopulation of pregnant women. The secondary study objective is to describe the treatment patterns of switching or discontinuation of valproate in valproate WCBP chronic users and in a subpopulation of pregnant women. The objectives will be split for each indication of valproate (epilepsy or bipolar disorder). This is a cohort study conducted with secondary data from the UK electronic medical records database (Clinical Practice Research Datalink) and the French nationwide claims (Système National des Données de Santé) which will include women aged 13 to 49 years, who have discontinued valproate from 2014 to 2017 and followed for 1 year or until the date of death or database eligibility lost. Pregnant population will be women with a pregnancy start between 9 months before index date and the end of follow up.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)EMEA/H/A-31/1454
Other study registration identification numbers and URLs as applicableNone
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.bordeauxpharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Bosco-Levy (Prince)
First name Pauline
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?2
Sanofi R&D, France
Countries in which this study is being conducted
International study

France
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/04/2019
Start date of data collection01/01/2021
Start date of data analysis01/01/2021
Date of interim report, if expected01/07/2021
Date of final study report01/07/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesA Consortium of Marketing Authorization Holders for valproate and related substances100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bosco-Levy (Prince)
First name Pauline
Address line 1Bordeaux PharmacoEpi, INSERM CIC1401
Address line 2Université de Bordeaux, Bâtiment le Tondu- Case 41 
Address line 3146 Rue Léo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Bosco-Levy (Prince) 
First name Pauline 
Address line 1Bordeaux PharmacoEpi, INSERM CIC1401 
Address line 2Université de Bordeaux, Bâtiment le Tondu- Case 41 
Address line 3146 Rue Léo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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