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

Ipsen239 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

239

Conditions

Spasticity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (11)

Hospital Bettina Ferro de Souza Campus IV da Universidade Federal do Pará

Belém, Brazil

Centro Catarinense de Reabilitação

Florianópolis, Brazil

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Goiânia, Brazil

Outcomes

Primary Outcomes

Change in Goal Achievement Score (GAS).

Time frame: 3 and 6 months

Secondary Outcomes

Change from baseline in pain according to Verbal Numerical Scale (VNS).

Time frame: Baseline and 3 months

Change from baseline in Modified Ashworth Scale (MAS) score

Time frame: Baseline and 3 months

Change from baseline in functional independence according to Barthel index score

Time frame: Baseline and 3 months

Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire

Time frame: Baseline and 3 months

Data from ClinicalTrials.gov

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