Post marketing surveillance (non-interventional study) for evaluating the efficacy and safety of Dysport Czech patients suffering from post-stroke arm spasticity

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27785
• EU PAS number:
  EUPAS27784
• Study ID:
  27785
• Official title and acronym:
  Post marketing surveillance (non-interventional study) for evaluating the efficacy and safety of Dysport Czech patients suffering from post-stroke arm spasticity
• DARWIN EU® study:
  No
• Study countries:
  Czechia
• Study description:
  To provide additional risk / benefit information on the use of Dysport within the approved indications. The Study is therefore non-interventional and is designed only to collect data that would normally be available in the standard treatment of patients with Dysport within licensed indication. As such, no additional measures of efficacy or safety are being collected other than those recorded in normal practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 9 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 12/02/2008

Actual: 12/02/2008

Study start date

Planned: 12/11/2008

Actual: 12/11/2008

Data analysis start date

Planned: 13/04/2012

Actual: 13/04/2012

Date of final study report

Planned: 30/04/2015

Actual: 13/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen

Study protocol

Initial protocol

A-38-52120-113_protocol-13Feb2012_Redacted

Regulatory

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