Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe the long term use of Botulinum Neurotoxin Type A (BoNT-A) in adult subjects affected with upper and/or lower limb spasticity who received treatment with BoNT-A for a minimum of three injections cycles at three Italian centers. The study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. Period of observation defined in the protocol is from 2008 to 2018, but it could change for each subject according to the number of injections cycles performed. Time frame for data collection is 12 months from study start.

Official Title
-----------------
A Retrospective Multicenter Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (Result Study)

Conditions
-----------------
Spasticity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged ≥18 years old at the time of the first BoNT-A injection Diagnosed with spasticity with any cause (excluded CP) Treated with a minimum of three BoNT-A treatment cycles for upper limb spasticity (ULS) and/or lower limb spasticity (LLS) With follow up data available in the subject's medical record Provision of written informed consent form, to the extent required according to applicable national local regulations for a retrospective, non-interventional study Exclusion Criteria: Treatments and assessments were performed at more than one centre

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total dose of BoNT-A | Average total dose per BoNT-A type in upper and/or lower limbs (this is the average total dose injected during all sessions per BoNT-A type during the study period) | From the baseline to the end of the study (12 months) | 
| Average interval between BoNT-A injections | Average interval between BoNT-A injections in upper and/or lower limbs for BoNT-A overall (regardless of BoNT-A type) and per BoNT-A type | From the baseline to the end of the study (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total dose per BoNT-A type in upper limbs | Average total dose per BoNT-A type in upper limbs in patients treated for upper and lower limbs | From the baseline to the end of the study (12 months) | 
| Average total dose per BoNT-A type in lower limbs | Average total dose per BoNT-A type in lower limbs in patients treated for upper and lower limbs | From the baseline to the end of the study (12 months) | 
| Number of BoNT-A injection cycles |  | From the baseline to the end of the study (12 months) | 
| Average total dose per muscle in upper limbs |  | From the baseline to the end of the study (12 months) | 
| Average total dose per muscle in lower limbs |  | From the baseline to the end of the study (12 months) | 
| Number of switches between BoNT-A preparations | Number of switches between BoNT-A preparations and reasons for switch (if known): due to no efficacy, persistent weak response in not fibrotic muscle, side effects, non-availability of the product | From the baseline to the end of the study (12 months) | 
| Reason for injection | Reported reason for injection at each cycle: due to medical need, scheduled visit, not recorded | From the baseline to the end of the study (12 months) | 
| Reason for interruption | Reported reason for BoNT-A interruptions (if applicable): side effects (excessive weakness, hematoma), no efficacy, fibrosis, contractures, long lasting clinical improvement, patients never showed up again | From the baseline to the end of the study (12 months) | 
| Occurrence of treatment discontinuation |  | From the baseline to the end of the study (12 months) | 
| Global Treatment Satisfaction (GTS) | The qualitative subjective evaluation of patient treatment satisfaction has to be collected from medical records. The physician registered the level of satisfaction from previous treatment (very satisfied, satisfied, a little satisfied, not satisfied). A numerical value is assigned to each answer in order to obtain a numerical, subjective, GTS scale. It is a 4 point scale easy to use and to elaborate for analysis | From the baseline to the end of the study (12 months) |