Effectiveness and Safety of SMART BoNT-A therapy with Dysport® in patients with post-stroke chronic upper limb spasticity in real-life setting (SMART-NIS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107723
• EU PAS number:
  EUPAS107722
• Study ID:
  107723
• Official title and acronym:
  Effectiveness and Safety of SMART BoNT-A therapy with Dysport® in patients with post-stroke chronic upper limb spasticity in real-life setting (SMART-NIS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Ipsen Pharma

Study timelines

Date when funding contract was signed

Actual: 28/10/2021

Study start date

Actual: 05/05/2022

Data analysis start date

Planned: 31/05/2025

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen Pharma

Study protocol

Updated protocol

CLIN-52120-456_protocol_V2.0_07Jul2023_Redacted_PDFA.pdf

Regulatory

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

Other study registration identification numbers and links

NCT05224349

Link to ClinicalTrials.gov