Non-interventional multi-country prospective cohort study to investigate patterns of use of Selincro® and frequency of adverse drug reactions in routine clinical practice (START)

Study identification

• EU PAS number:
  EUPAS5678
• Study ID:
  16904
• Official title and acronym:
  Non-interventional multi-country prospective cohort study to investigate patterns of use of Selincro® and frequency of adverse drug reactions in routine clinical practice (START)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Denmark

  France

  Germany

  Greece

  Italy

  Poland

  Portugal

  Romania

  Sweden

  United Kingdom
• Study description:
  The aim of this study is to investigate patterns of use of Selincro® and frequency of adverse drug reactions in routine clinical practice
• Study status:
  Finalised

Research institutions and networks

Institutions

H. Lundbeck

Study timelines

Date when funding contract was signed

Planned:03/06/2013

Actual:03/06/2013

Study start date

Planned:30/06/2014

Actual:28/08/2014

Data analysis start date

Planned:30/06/2016

Actual:25/07/2016

Date of interim report, if expected

Planned:30/12/2016

Actual:12/12/2016

Date of final study report

Planned:28/06/2019

Actual:19/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

H. Lundbeck A/S

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)