Clinical trial NCT04604379: A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity
Official title: A Multicentre, Non-interventional Retrospective Study of Treatment Outcomes From Treatment With Dysport ® (Clostridium Botulinum Type A Toxin-haemagglutinin Complex, Abobotulinumtoxin-A) Injections in Adults for Upper and/or Lower Limb Focal Spasticity in Real-world Clinical Practice in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper and/or Lower Limb Focal Spasticity
Keywords: Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3-5 Secondary care centres in the UK

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).


Eligibility criteria: 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

Primary outcomes:
measure: Average total dose of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session
timeFrame: From baseline (when each patient received their first treatment) to 52 weeks (±6 weeks) post baseline
measure: Average interval between AboBoNT-A injections throughout the observation period for focal ULS and/or LLS
timeFrame: From baseline to 52 weeks (±6 weeks) post baseline
Secondary outcomes:
measure: Average age at diagnosis of neurological condition
timeFrame: Baseline
measure: Average age at first AboBoNT-A injection
timeFrame: Baseline
measure: Average age at diagnosis of spasticity
timeFrame: Baseline
measure: Sex distribution (Male, Female)
timeFrame: Baseline
measure: Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse.
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
city: Norwich
country: United Kingdom
facility: Colman Hospital
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: