Status: Planned First registered on: 01/04/2020
Last updated on: 28/04/2020
1. Study identification
EU PAS Register NumberEUPAS34465
Official titleSurveys among Health Care Professionals and Patients to assess their knowledge and behaviour with respect to the new (2018) Risk Minimization Measures for valproate use in Europe.
Study title acronymVALNAC09348
Study typeOther: Survey
Brief description of the studyThis survey aims to measure the awareness, knowledge and behaviour of prescribing physicians, gynaecologists and pharmacists with respect to the new (2018) RMMs for valproate, as well as of patients treated with valproate in France, Germany, Poland, Sweden, Spain and UK. The new RMMs include new prescribing and dispensing conditions, Pregnancy Prevention Program (PPP), educational materials (EM) i.e. Healthcare Professionals (HCPs) guide, Patient Card, Patient Guide, and Annual Risk Acknowledgement form. Objectives for HCPs - To assess HCPs awareness related to both receipt and reading of the new (2018) RMMs including direct healthcare professional communication (DHPC) and educational materials (EMs) for valproate-containing medicines. - To assess HCPs knowledge with respect to the new (2018) RMMs including measures of PPP, prescribing/dispensing conditions and risks associated with exposure to valproate-containing medicines during pregnancy. - To assess HCPs behaviour with respect to the new (2018) RMMs regarding the measures of the PPP. Objectives for Patients - To assess the awareness of women of child bearing potential (WCBP) treated with valproate-containing medicines related to both receipt and reading of the new (2018) RMMs including the educational materials provided by the HCPs. - To assess the knowledge of WCBP treated with valproate-containing medicines with regards to risks associated with use of valproate-containing medicines during pregnancy and measures to avoid exposed pregnancies. - To assess the behaviour of WCBP treated with valproate-containing medicines with respect to the new (2018) RMMs including measures of the PPP. Data collection Mainly web questionnaire, paper version proposed to patients, pharmacists not be surveyed in France. Sample size: - 1328 completed questionnaires from physicians who have prescribed valproate, 215 from gynaecologists having seen patients treated with valproate, - 384 completed questinnaires
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
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Poland
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 collection01/06/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report01/02/2021
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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