Study identification

PURI

https://redirect.ema.europa.eu/resource/49662

EU PAS number

EUPAS32405

Study ID

49662

Official title and acronym

Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence (ValproateRiskAware)

DARWIN EU® study

No

Study countries

Belgium
Denmark
Greece
Latvia
Netherlands
Portugal
Slovenia
Spain

Study description

This 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.

Study status

Finalised
Research institution and networks

Institutions

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

Networks

Contact details

Olaf Klungel

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

29-01-2020 Protocol valproate study version 2.0 final with annexes

English (634.51 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable