Drug utilization study of dexamfetamine in European countries (DUS of dexamfetamine)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43102
• EU PAS number:
  EUPAS7778
• Study ID:
  43102
• Official title and acronym:
  Drug utilization study of dexamfetamine in European countries (DUS of dexamfetamine)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Germany

  Ireland

  Netherlands

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a retrospective database analysis to provide data on drug utilization on an annual basis for up to 5 years. Objectives are • to describe how dexamfetamine is prescribed in Europe • to evaluate off-label use in Europe • to collect data on abuse, misuse, overdose, diversion and dependence related to dexamfetamine
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 31/10/2014

Actual: 27/04/2016

Study start date

Planned: 30/09/2015

Actual: 01/05/2016

Data analysis start date

Planned: 01/06/2016

Actual: 01/06/2016

Date of interim report, if expected

Planned: 13/11/2018

Actual: 13/11/2018

Date of final study report

Planned: 31/12/2020

Actual: 14/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Medice

Study protocol

Initial protocol

Dexamfetamine DUS Protocol V2-1 08-09-2015 privacy

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)