Upper and/or Lower Limb Focal SpasticityDYSCOVERNCT04604379
A Study to Review Treatment Outcomes From Treatment With Dysport® Injections in Adults for Upper and/or Lower Limb Focal Spasticity
An observational study of Upper and/or Lower Limb Focal Spasticity, run by Ipsen at 3 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper and/or Lower Limb Focal Spasticity
- How many people
- 123 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 4 Feb 2021to 28 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3-5 Secondary care centres in the UK
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Kings College Hospital
London
Colman Hospital
Norwich
York Hospital
York
About this study
Official 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
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).
- Conditions
- Upper and/or Lower Limb Focal Spasticity
- Keywords
- Spasticity
- Medical subject headings
- Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total dose of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session
Measured: 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
Measured: From baseline to 52 weeks (±6 weeks) post baseline
Secondary outcomes (8)
Average age at diagnosis of neurological condition
Measured: Baseline
Average age at first AboBoNT-A injection
Measured: Baseline
Average age at diagnosis of spasticity
Measured: Baseline
Sex distribution (Male, Female)
Measured: Baseline
Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other)
Measured: 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)
Measured: 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
Measured: Baseline
Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start4 Feb 2021
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper and/or Lower Limb Focal SpasticityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604379
- Sponsor's protocol ID
- A-GB-52120-277
- Acronym
- DYSCOVER
- Status last verified
- Jun 2021
- First submitted
- 21 Oct 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04604379
- Acronym / sponsor ID
- DYSCOVER / A-GB-52120-277
- Conditions
- Upper and/or Lower Limb Focal Spasticity
- Keywords
- Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3-5 Secondary care centres in the UK
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
8 secondary outcomes
Average age at diagnosis of neurological condition
Time frame: Baseline
Average age at first AboBoNT-A injection
Time frame: Baseline
Average age at diagnosis of spasticity
Time frame: Baseline
Sex distribution (Male, Female)
Time frame: Baseline
Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other)
Time frame: 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)
Time frame: 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
Time frame: Baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper and/or Lower Limb Focal Spasticity, run by Ipsen at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.