Upper and/or Lower Limb Focal Spasticity
Conditions
Keywords
Spasticity
Brief summary
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).
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
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Average age at diagnosis of neurological condition | 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 | — |
| 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) | Baseline | Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment) |
| Average age at first AboBoNT-A injection | Baseline | — |
Countries
United Kingdom
Outcome results
None listed