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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-04

Study Completion Date

2021-05-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Upper and/or Lower Limb Focal Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No