Status: Planned First registered on: 03/04/2020
Last updated on: 28/04/2020
1. Study identification
EU PAS Register NumberEUPAS34519
Official titleA Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases
Study title acronymVALNAC09343
Study typeObservational study
Brief description of the studyThe aim of this study is to describe the prescribing practices before and after the dissemination of the new risk minimization measures (RMMs) (planned over Q2 2018 – Q4 2018, depending on approval by National Competent Authorities) in Europe and to assess the effectiveness of these measures. Primary objectives: • To describe and compare the prescribing practices in women of child bearing potential (WCBP) receiving valproate during the pre- and/or post-implementation period with respect to elements of the PPP (where available in each of the data sources) separately: o Use of contraceptives without interruption during treatment o Laboratory pregnancy tests before treatment o Treatment reviews by a specialist at least once per year (using a proxy of consultation by a specialist as a marker for treatment review) o Specialty of prescribing physician at initiation • To describe and compare proportion of patients for which all elements of the PPP measurable with this DUS are fulfilled, during the pre- and/or post-implementation period • To describe and compare the incidence of valproate exposed pregnancies, and characteristics of exposed pregnancies during the pre and post implementation period This is a non-interventional longitudinal retrospective cohort study of WCBP exposed to valproate, conducted with secondary data obtained from electronic medical records or administrative healthcare databases in different European countries (i.e. France, Germany, the Netherlands, Spain, Sweden, and the UK). The study population will include all WCBP receiving valproate prescriptions during the pre-defined periods (pre- and post-implementation periods). The analyses will be mainly descriptive and will be conducted by country, database, and study time periods.
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 applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research group
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
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?6
Countries in which this study is being conducted
International study

France
Germany
Netherlands
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/10/2018
Start date of data collection01/08/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report28/02/2024
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 Toussi
First name Massoud
Address line 1Tour D2
Address line 217 bis Place des Reflets 
Address line 3 
CityCourbevoie 
Postcode92090 
CountryFrance
Phone number (incl. country code)33607966650 
Alternative phone number 
Fax number (incl. country code) 
Email address massoud.toussi@iqvia.com
Public Enquiries
Title Dr 
Last name Toussi 
First name Massoud 
Address line 1Tour D2 
Address line 217 bis Place des Reflets 
Address line 3 
CityCourbevoie 
Postcode92090 
CountryFrance 
Phone number (incl. country code)33607966650 
Alternative phone number 
Fax number (incl. country code) 
Email address massoud.toussi@iqvia.com 
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