A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity

Study Overview
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Brief Summary
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The aim of this retrospective study is to describe the real-world outcomes with the treatment of adult patients with Dysport® injections for focal upper limb spasticity (ULS) and/or focal lower limb spasticity (LLS) in NHS hospital settings in the United Kingdom (UK).

Official Title
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A Multicentre, Non-interventional Retrospective Study of Treatment Outcomes From Treatment With Dysport ® (Clostridium Botulinum Type A Toxin-haemagglutinin Complex, Abobotulinumtoxin-A) Injections in Adults for Upper and/or Lower Limb Focal Spasticity in Real-world Clinical Practice in the United Kingdom

Conditions
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Upper and/or Lower Limb Focal Spasticity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients diagnosed with focal ULS and/or LLS for whom aboBoNT-A (Dysport®) was prescribed in line with the SmPC (according to clinician judgement). Patients initiated on aboBoNT-A for focal ULS after the 31st January 2016 and/or for focal LLS after the 06th December 2016. Patients receiving ≥1 injection(s) (i.e. ≥1 treatment cycle) of aboBoNT-A during the observation period, in line with Dysport® Summary of Product Characteristics (SmPC). Patients aged ≥18 years old at the time of the first aboBoNT-A injection for focal ULS and/or LLS. Patient is naïve to treatment with any type of BoNT-A during the 6 months prior to initiation of aboBoNT-A. Patients treated at the participating centre for the duration of the observation period, with data recorded in the medical records available for review. Exclusion Criteria: Patients with an interval of <12 weeks between aboBoNT-A treatments Patients are participating (or who have participated) in an interventional clinical trial of an investigational medicinal product indicated for spasticity which may influence and confound the real-world data collected for this study. Patients treated with aboBoNT-A off-license, this may include off-license indications, muscles indicated for injection or dosing

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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No

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 of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session |  | From baseline (when each patient received their first treatment) to 52 weeks (±6 weeks) post baseline | 
| Average interval between AboBoNT-A injections throughout the observation period for focal ULS and/or LLS |  | From baseline to 52 weeks (±6 weeks) post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average age at diagnosis of neurological condition |  | Baseline | 
| Average age at first AboBoNT-A injection |  | Baseline | 
| Average age at diagnosis of spasticity |  | Baseline | 
| Sex distribution (Male, Female) |  | Baseline | 
| Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other) |  | Baseline | 
| Presence of location of spasticity (specify: right lower limb, left lower limb, right upper limb, left upper limb, unilateral, bilateral spasticity for lower and upper limb) | Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment) | Baseline | 
| Presence of previous spasticity-related treatments ongoing at index event, if available: antispasticity medications, pain medications and opioids, neurolytic agent, surgery, physiotherapy and occupational therapy |  | Baseline | 
| Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse. |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity