Upper and/or Lower Limb Focal Spasticity Clinical Trial
— DYSCOVEROfficial 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
| Verified date | June 2021 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 123 |
| Est. completion date | May 28, 2021 |
| Est. primary completion date | May 28, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | Colman Hospital | Norwich | |
| United Kingdom | York Hospital | York |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | 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 | Average age at diagnosis of neurological condition | Baseline | ||
| Secondary | Average age at first AboBoNT-A injection | Baseline | ||
| Secondary | Average age at diagnosis of spasticity | Baseline | ||
| Secondary | Sex distribution (Male, Female) | Baseline | ||
| Secondary | Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other) | Baseline | ||
| Secondary | 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) | Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment) | Baseline | |
| Secondary | 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 | ||
| Secondary | Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse. | Baseline |