Spasticity
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | Outcome will be assessed according following reasons: due to medical need, unplanned need and not recorded |
| 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 | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019). | 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. |
| Changes in Modified Ashworth Scale (MAS) scores by time period per muscle | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 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. |
| Baseline subjects characteristics | Baseline (first Dysport® injection) | * Demography (age at first injection during the period of interest, sex, weight) * History of spasticity |
| Changes in Pain score according to pain Visual Analogue Scales (VAS) | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 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. |
| Gait pattern evaluation in patients with LLS | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 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 |
| Concomitant drugs for the management of patients with ULS +/- LLS | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 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. |
| Non-drug concomitant therapies for the management of patients with ULS +/- LLS | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | List the non-drug concomitant therapies, including occupational therapy, physiotherapy and others (e.g.: orthotics, serial casting, splinting, electric stimulation) |
| Incidence and intensity of Adverse Events | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 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 |
| Changes in Functional Independence Measure (FIM) subscales | From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019) | 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. |
| 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) | — |
Countries
Brazil
Outcome results
None listed