Use of Nalmefene (Selincro®) in European databases: Cohort design using longitudinal electronic medical records or claims databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16907
• EU PAS number:
  EUPAS14083
• Study ID:
  16907
• Official title and acronym:
  Use of Nalmefene (Selincro®) in European databases: Cohort design using longitudinal electronic medical records or claims databases
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Sweden

  United Kingdom
• Study description:
  Databases analyses in several European countries have been proposed to investigate patterns of use of Selincro® in real clinical practice taking into account the important risks and missing information documented in the RMP.
• Study status:
  Ongoing

Research institutions and networks

Institutions

H. Lundbeck

Study timelines

Date when funding contract was signed

Planned: 15/11/2013

Actual: 15/07/2013

Study start date

Planned: 01/08/2016

Actual: 01/08/2016

Data analysis start date

Planned: 02/08/2016

Actual: 02/08/2016

Date of interim report, if expected

Planned: 31/07/2017

Date of final study report

Planned: 28/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

H. Lundbeck A/S

Study protocol

Initial protocol

15649A version 3 0 09 MAR 2015 Abstract for Encepp

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)