A post marketing surveillance survey of Dysport for evaluating safety of Dysport in Korean patients suffering from Spasticity or Dystonia

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35504
• EU PAS number:
  EUPAS35503
• Study ID:
  35504
• Official title and acronym:
  A post marketing surveillance survey of Dysport for evaluating safety of Dysport in Korean patients suffering from Spasticity or Dystonia
• DARWIN EU® study:
  No
• Study countries:
  Korea, Democratic People's Republic of
• Study description:
  This is an open, non-randomised, multi-centre, non-interventional, post-marketing survey to collect safety data based on routine treatment of subjects with spasticity or dystonia.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 13 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 02/08/2006

Study start date

Planned: 08/01/2006

Actual: 08/02/2006

Data analysis start date

Planned: 31/01/2007

Actual: 15/03/2007

Date of final study report

Planned: 31/12/2015

Actual: 20/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen

Study protocol

Initial protocol

a3852120114-protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable