A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases

Study identification

• EU PAS number:
  EUPAS9678
• Study ID:
  32834
• Official title and acronym:
  A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden

  United Kingdom
• Study description:
  The 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 15/06/2015

Actual: 01/03/2016

Study start date

Planned: 31/03/2016

Actual: 31/03/2016

Data analysis start date

Planned: 15/06/2016

Actual: 15/06/2016

Date of interim report, if expected

Planned: 31/01/2017

Actual: 23/12/2016

Date of final study report

Planned: 31/08/2019

Actual: 28/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Consoritum of 22 MAH, led by Sanofi Aventis

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)