Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA

Study Overview
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Brief Summary
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The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.

Official Title
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Retrospective Real-life Study From One Brazilian Reference Centre Assessing Long-term Experience in the Treatment of Adult Spasticity With AbobotulinumtoxinA (RETURN Study)

Conditions
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Spasticity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged ≥18 years old at the time of the first Dysport® injection Diagnosed with spasticity Treated with a minimum of three Dysport® injection cycles for ULS +/- LLS in the observational period Follow up effectiveness data are available in the subject's medical record Exclusion Criteria: Patients have received previous treatment with another BoNT-A less than 12 weeks prior to the patient data collection in the study Adults with cerebral palsy Patients treated with BoNT-A in a clinical trial setting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total dose injected during all sessions of Dysport® in ULS +/- LLS |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Median total dose injected during all sessions of Dysport® in ULS +/- LLS |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Average interval between Dysport® injections in ULS +/- LLS |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline subjects characteristics | Demography (age at first injection during the period of interest, sex, weight) History of spasticity | Baseline (first Dysport® injection) | 
| Total number of Dysport® injection cycles |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Total time exposure to Dysport® treatment in ULS +/- LLS |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Total dose injected per cycle, per limb, per muscle and overall |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Number of muscles injected in ULS +/- LLS |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Reported reason for Dysport® injection and for change | Outcome will be assessed according following reasons: due to medical need, unplanned need and not recorded | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Number of Dysport® interruptions |  | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Reasons of Dysport® discontinuation | Outcome will be assessed according following reasons: side effects (e.g. excessive weakness, hematoma), contractures, absence of clinical response, long lasting clinical improvement, patient lost follow up and other. | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019). | 
| Changes in Modified Ashworth Scale (MAS) scores by time period per muscle | The MAS is a six-point scale to grade muscle tone in the injected muscle from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). Upper limb: shoulder abduction, elbow flexion, elbow extension, wrist flexion, wrist extension and fingers flexion. Lower limb: hip flexion, hip adduction, hip abduction, knee flexion, knee extension, ankle dorsiflexion and ankle plantar flexion. | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Changes in Functional Independence Measure (FIM) subscales | Subscales and total scores of FIM will be measured. The FIM is a method for categorising patients on a seven-point scale (range 1 to 7). It comprises of 18 items, grouped into 2 subscales (motor and cognition). The motor subscale includes: eating, grooming, bathing, dressing upper body, dressing lower body, toileting, bladder management, bowel management, transfers - bed/chair/wheelchair, transfers - toilet, transfers - bath/shower, walk/wheelchair and stairs. The cognition subscale includes: comprehension, expression, social interaction, problem solving and memory. The Scores are summed to obtain a total score that can range between 18 and 126. | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Changes in Pain score according to pain Visual Analogue Scales (VAS) | The pain Visual Analogue Scale (VAS) is a numeric graphic rating scale (NGRS) of self-reported symptoms. Scores are recorded as whole numbers between zero and 10, where zero indicates no pain symptom at all, and 10 indicates a as bad as it could be. | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Gait pattern evaluation in patients with LLS | Gait Pattern Modification in patients with LLS is based on physician´s clinical evaluation and it will be evaluated for each lower limb (left and right) or both according to pre-specified patterns: equinismus, foot inversion, knee hyperextension, adduction, mowing abduction, thigh elevation, hip elevation, false trendelenburg, not able to walk. The Gait Pattern Improvement is described based on patient´s perception of gait. The patients respond Yes or No and if Yes the % of improvement is replied | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Concomitant drugs for the management of patients with ULS +/- LLS | List the systemic drug therapies, including: antispasticity medications (e.g. Baclofen, Tizanidin, Dantrolene), simple pain medications (e.g. paracetamol or NSAIDS), neuropathic pain and spasticity medications (e.g. Gabapentin, Pregabalin, Amitriptyline), opioids, phenol, alcool or other neurolytic agents. | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Non-drug concomitant therapies for the management of patients with ULS +/- LLS | List the non-drug concomitant therapies, including occupational therapy, physiotherapy and others (e.g.: orthotics, serial casting, splinting, electric stimulation) | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 
| Incidence and intensity of Adverse Events | Adverse events will be assessed according to incidence, intensity/grade (mild, moderate and severe), causality (related and not related to the product), outcome (the overall association between an exposure to a drug and an outcome) and action taken. All Adverse Events (AEs) (including fatal events and Serious Adverse Events (SAEs)) and special situation (pregnancy, overdose, off-label use) will be reported with the number and proportion of events. The incidence will be provided and classified by System Organ Class and Preferred Term | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) |