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

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

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).

Study Overview

• Status: Completed
• Conditions: Upper and/or Lower Limb Focal Spasticity

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Kings College Hospital
  • Norwich, United Kingdom
    • Colman Hospital
  • York, United Kingdom
    • York Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

3-5 Secondary care centres in the UK

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)	Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment)	Baseline
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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Spasticity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: A-GB-52120-277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No