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Completed

NCT Number: NCT04604379

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

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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Key information

Conditions

Upper and/or Lower Limb Focal Spasticity Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kings College Hospital, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Average total dose of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session

    Time frame: From baseline (when each patient received their first treatment) to 52 weeks (±6 weeks) post baseline

  2. Average interval between AboBoNT-A injections throughout the observation period for focal ULS and/or LLS

    Time frame: From baseline to 52 weeks (±6 weeks) post baseline

Secondary outcomes

  1. Average age at diagnosis of neurological condition

    Time frame: Baseline

  2. Average age at first AboBoNT-A injection

    Time frame: Baseline

  3. Average age at diagnosis of spasticity

    Time frame: Baseline

  4. Sex distribution (Male, Female)

    Time frame: Baseline

  5. Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other)

    Time frame: Baseline

  6. 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)

    Time frame: Baseline

    Data collected at index date up to 6 weeks prior to index date (when each patient received their first treatment)

  7. 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

    Time frame: Baseline

  8. Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: DYSCOVER

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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