Drug utilisation study of Intuniv® (guanfacine extended release) in European Countries – A prescriber survey (Intuniv survey study Europe)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48514
• EU PAS number:
  EUPAS18739
• Study ID:
  48514
• Official title and acronym:
  Drug utilisation study of Intuniv® (guanfacine extended release) in European Countries – A prescriber survey (Intuniv survey study Europe)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Finland

  Ireland

  Netherlands
• Study description:
  This is a multinational, cross-sectional, non-interventional and anonymous survey to assess drug utilisation of Intuniv which is indicated for treatment of attention deficit hyperactivity disorder. The survey will be carried out among physicians who will be asked to provide de-identified patient data. The survey will be conducted through a web-questionnaire among prescribers of Intuniv® in four European countries (Belgium, Finland, Ireland, Netherlands). In other countries utilization of Intuniv will be assessed in a database analysis which is described in a separate protocol.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 30/08/2016

Actual: 30/08/2016

Study start date

Planned: 01/02/2019

Actual: 20/02/2019

Date of interim report, if expected

Planned: 30/06/2019

Actual: 11/06/2019

Date of final study report

Planned: 30/06/2022

Actual: 16/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Pharmaceutical Company Limited

Study protocol

Updated protocol

INTUNIV EU DUS_SURVEY Protocol v5.0_17Jul2018_redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)