A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity
Completed
- Conditions
- Upper and/or Lower Limb Focal Spasticity
- Registration Number
- NCT04604379
- Lead Sponsor
- Ipsen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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) Baseline Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment)
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
Trial Locations
- Locations (3)
York Hospital
🇬🇧York, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Colman Hospital
🇬🇧Norwich, United Kingdom