Status: Finalised First registered on: 07/05/2015
Last updated on: 18/12/2019
1. Study identification
EU PAS Register NumberEUPAS9678
Official titleA Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of this study is to describe the prescribing practices before and after the dissemination of risk minimisation measures (i.e. educational materials and Dear Healthcare Professional Communication) and to assess the effectiveness of these measures in females through measure of prevalence of prior medication used before valproate.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 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
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/06/201501/03/2016
Start date of data collection31/03/201631/03/2016
Start date of data analysis15/06/201615/06/2016
Date of interim report, if expected31/01/201723/12/2016
Date of final study report31/08/201928/06/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesConsoritum of 22 MAH, led by Sanofi Aventis100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Massoud
First name Toussi
Address line 117 bis Place des Reflets
Address line 2Tour D2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com
Public Enquiries
Title Dr 
Last name Massoud 
First name Toussi 
Address line 117 bis Place des Reflets 
Address line 2Tour D2 
Address line 3 
CityParis La Défense 
Postcode92088 
CountryFrance 
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address mtoussi@fr.imshealth.com 
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