Status:

COMPLETED

Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)

Lead Sponsor:

Ipsen

Conditions:

Post-stroke Arm Spasticity

Eligibility:

All Genders

25+ years

Brief Summary

Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms. The hypothesis for this non-interventional study in arm spastici...

Eligibility Criteria

Inclusion

  • Written informed consent prior to data collection
  • Hemiparesis and clinically relevant upper limb post-stroke spasticity
  • Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC
  • BoNT naïve or pre-treated with any BoNT product

Exclusion

  • Recurrent stroke
  • Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®

Key Trial Info

Start Date :

March 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 6 2018

Estimated Enrollment :

302 Patients enrolled

Trial Details

Trial ID

NCT01840475

Start Date

March 1 2013

End Date

February 6 2018

Last Update

March 31 2020

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Hermagor, Austria

2

Bidart, France

3

Berlin, Germany

4

Zwolle, Netherlands

Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation) | DecenTrialz