Status: Planned First registered on: 20/11/2019
Last updated on: 18/02/2020
1. Study identification
EU PAS Register NumberEUPAS32405
Official titleImpact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence
Study title acronymValproateRiskAware
Study typeOther: Cross-sectional
Brief description of the studyThis is a multi-country study in eight European countries: Belgium, Denmark, Greece, Latvia, Portugal, The Netherlands, Slovenia and Spain. In each country a web-based questionnaire will be conducted among users and former users of valproate and related products, and among health care professionals. An electronic survey including questions on the influence of regulatory recommendations on HCP awareness about the teratogenic and neurodevelopment effects of valproate and related substances will be used to gauge their perspective and to assess effects on knowledge, attitudes and practices. Similary a patient questionnaire will measure awareness about regulatory recommendations as well as uptake of pregnancy prevention measures, and investigate their effect on valproate use. Data from the survey and questionnaire will be anonymised and analysed for differences between countries. Determinants for adherence to the measures implemented per country will be analysed. Additionally, in two countries (Netherlands and Portugal) semi-structured telephone interviews will be held with 6-8 patients with a range in age and varied educational background.
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 belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/pecp
Details of (Primary) lead investigator
Title Dr
Last name Klungel
First name Olaf
Is this study being carried out with the collaboration of a research network?
Yes
Pharmacoepidemiology and Pharmacovigilance Network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?9

The Institute of Public Health of Riga Stradins University, Riga, Latvia
University of Copenhagen, Faculty of Health and Medical Sciences, Department of Pharmacy (Social and Clinical Pharmacy), Copenhagen, Denmark
Sección de Innovación y Organización, Servicio Navarro de Salud, Pamplona, Spain
Pharmaceutical Care Unit – Ghent University, Ghent, Belgium
Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, Netherlands
Countries in which this study is being conducted
International study

Belgium
Denmark
Greece
Latvia
Netherlands
Portugal
Slovenia
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/02/201925/02/2019
Start date of data collection25/10/2019
Start date of data analysis25/12/2019
Date of interim report, if expected24/07/2020
Date of final study report28/08/2020
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 Leonardo Alves
First name Teresa
Address line 1National Institute for Public Health and the Environment (RIVM)
Address line 2Centre for Health Protection (GZB) 
Address line 3P.O.Box 1, 
CityBilthoven 
Postcode3720 BA 
CountryNetherlands
Phone number (incl. country code)31-30-2743238 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Leonardo Alves 
First name Teresa 
Address line 1National Institute for Public Health and the Environment (RIVM 
Address line 2Centre for Health Protection (GZB) 
Address line 3P.O.Box 1, 
CityBilthoven 
Postcode3720 BA 
CountryNetherlands 
Phone number (incl. country code)31-30-2743238 
Alternative phone number 
Fax number (incl. country code) 
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