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

Ipsen

Status: Completed

Conditions: Post-stroke Arm Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT01840475

A-94-52120-174

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 25+ years old

Volunteers: No 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®

Trial design

302 participants in 2 patient groups

Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve

Description:

Subjects naïve to BoNT-A treatment.

Botulinum toxin type A (BoNT-A) Pre-treated

Description:

Subjects pre-treated with BoNT-A. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics \[SmPC\]).