A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity (DYSCOVER)

Ipsen

Status: Completed

Conditions: Upper and/or Lower Limb Focal Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT04604379

A-GB-52120-277

Details and patient eligibility

About

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).

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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