International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-stroke Arm Spasticity
- Sponsor
- Ipsen
- Enrollment
- 302
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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®
Outcomes
Primary Outcomes
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).
Time Frame: 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 Outcomes
- 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)