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

Completed

• Conditions: Post-stroke Arm Spasticity

• Registration Number: NCT01840475
• Lead Sponsor: Ipsen

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 spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• 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 Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).	Final study visit: approximately 20 months after first visit	"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A.; Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).

Secondary Outcome Measures

Name	Time	Method
Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).	Approximately every 4 months starting from baseline up to 2 years	"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A.; Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).