An observational study in Spasticity, sponsored by Ipsen. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by Ipsen · Observational
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
All eligible adult patients having received Dysport® for at least three cycles for the treatment of ULS +/- LLS between January 1st, 2006 and July 31st, 2019 at Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil with pre- and post-injection effectiveness data available will be enrolled.
Exclusion Criteria:
Average total dose injected during all sessions of Dysport® in ULS +/- LLS
Time frame: 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
Time frame: 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
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Baseline subjects characteristics
* Demography (age at first injection during the period of interest, sex, weight) * History of spasticity
Time frame: Baseline (first Dysport® injection)
Total number of Dysport® injection cycles
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Number of Dysport® interruptions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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