Study on the Use of Botulinum Toxin Type A in the Treatment of Chronic Post-stroke Spastic Patients

An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A (BoNT-A) Injections in Untreated Chronic Post-stroke Spastic Brazilian Patients

The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.

As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician.

This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice.

This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.

Inclusion Criteria:

• Time between last documented stroke (either haemorrhagic or ischemic) and study inclusion date equal or longer than 1 year
• Documented upper limb spasticity, with or without lower limb spasticity
• Naive to BoNT-A injections for spasticity treatment
• Provide written informed consent (signed by the patient or his legal representative) prior to any study-related procedure

Exclusion Criteria:

• Previous surgical procedure for spasticity treatment, including neurotomy, rhizotomy and intrathecal pump implants
• Previous phenol injection and/or indication to receive phenol during the study duration
• Contraindications to any BoNT-A preparations
• Patient and/or caregiver unable to comply with the study requirements
• The patient has already been included in the study