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CompletedNCT04604379DYSCOVERUpdated Jun 21, 2021

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

An observational study in Upper and/or Lower Limb Focal Spasticity, sponsored by Ipsen. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
123
Ages
18 Years and older
Sex
All
01

Study summary

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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Conditions studied

  • Upper and/or Lower Limb Focal Spasticity

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Keywords

  • Spasticity
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 123 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

3-5 Secondary care centres in the UK

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
123 participants (actual)
Patient registry
No
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What researchers measure

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)

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

    Time frame: Baseline

  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

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Study locations

3 sites
  • Kings College Hospital
    London, United Kingdom
  • Colman Hospital
    Norwich, United Kingdom
  • York Hospital
    York, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04604379
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Oct 27, 2020
Start date
Feb 4, 2021
Primary completion
May 28, 2021
Completion
May 28, 2021
Last update
Jun 21, 2021

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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