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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Spasticity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Botulinum toxin type A (BoNT-A) injection Naïve<br>Subjects naïve to BoNT-A treatment. Investigators follow their individual injection protocol for treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics and locally agreed therapeutic guidelines). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Goal Achievement Score (GAS). |  | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain according to Verbal Numerical Scale (VNS). |  | Baseline and 3 months | 
| Change from baseline in Modified Ashworth Scale (MAS) score |  | Baseline and 3 months | 
| Change from baseline in functional independence according to Barthel index score |  | Baseline and 3 months | 
| Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire |  | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Spasticity, Botulinum Toxin type A, Dysport