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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01840475

Acronym

EARLYBIRD

Enrollment

302

Registered

2013-04-25

Start date

2013-03-31

Completion date

2018-02-06

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Arm Spasticity

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

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®

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Austria, France, Germany, Netherlands, Switzerland

Outcome results