Retrospective Chart Review to Evaluate the Effectiveness of the Risk Minimization Measures for the Use of Flupirtine 100 mg Immediate-Release Capsules in daily Practice (Flupirtine-3300)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28844
• EU PAS number:
  EUPAS11134
• Study ID:
  28844
• Official title and acronym:
  Retrospective Chart Review to Evaluate the Effectiveness of the Risk Minimization Measures for the Use of Flupirtine 100 mg Immediate-Release Capsules in daily Practice (Flupirtine-3300)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Portugal
• Study description:
  This is a company-sponsored international, multicenter, non-interventional post-authorization safety study (PASS) in the form of a retrospective chart review (RCR) in a cohort of outpatients treated with flupirtine IR in daily practice in Germany and Portugal. The overall research goal is to assess the effectiveness of the risk minimization measures for flupirtine 100 mg immediate-release capsules (flupirtine IR) by evaluating to which extent these measures are implemented in daily practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

MEDA Pharma

Multiple centres: 120 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/10/2015

Actual: 15/10/2015

Study start date

Planned: 01/11/2015

Actual: 03/03/2016

Date of final study report

Planned: 31/12/2016

Actual: 09/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MEDA Pharma

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)