European multicenter retrospective-prospective cohort study to observe Safinamide safety profile and pattern of use in clinical practice during the first post-commercialization phase - Study Z7219N02 (SYNAPSES)

Study identification

• EU PAS number:
  EUPAS13745
• Study ID:
  41165
• Official title and acronym:
  European multicenter retrospective-prospective cohort study to observe Safinamide safety profile and pattern of use in clinical practice during the first post-commercialization phase - Study Z7219N02 (SYNAPSES)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Italy

  Spain

  Switzerland

  United Kingdom
• Study description:
  No information provided.
• Study status:
  Finalised

Research institutions and networks

Institutions

Zambon

Multiple centres: 128 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:22/12/2015

Actual:27/04/2016

Study start date

Planned:30/06/2016

Actual:04/08/2016

Date of final study report

Planned:31/10/2019

Actual:06/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Zambon SpA

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)