SpasticityRETURNNCT04446702
Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA
An observational study of Spasticity, run by Ipsen at 1 site in Brazil.
Trial summary
The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spasticity
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2021to 10 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible adult patients having received Dysport® for at least three cycles for the treatment of ULS +/- LLS between January 1st, 2006 and July 31st, 2019 at Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil with pre- and post-injection effectiveness data available will be enrolled.
Who may be able to join
- Adult aged ≥18 years old at the time of the first Dysport® injection
- Diagnosed with spasticity
- Treated with a minimum of three Dysport® injection cycles for ULS +/- LLS in the observational period
- Follow up effectiveness data are available in the subject's medical record
Who cannot join
- Patients have received previous treatment with another BoNT-A less than 12 weeks prior to the patient data collection in the study
- Adults with cerebral palsy
- Patients treated with BoNT-A in a clinical trial setting
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP)
São Paulo
About this study
Official title: Retrospective Real-life Study From One Brazilian Reference Centre Assessing Long-term Experience in the Treatment of Adult Spasticity With AbobotulinumtoxinA (RETURN Study)
The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.
- Conditions
- 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 injected during all sessions of Dysport® in ULS +/- LLS
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Median total dose injected during all sessions of Dysport® in ULS +/- LLS
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Average interval between Dysport® injections in ULS +/- LLS
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Secondary outcomes (15)
Baseline subjects characteristics
- Demography (age at first injection during the period of interest, sex, weight)
- History of spasticity
Measured: Baseline (first Dysport® injection)
Total number of Dysport® injection cycles
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Total time exposure to Dysport® treatment in ULS +/- LLS
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Total dose injected per cycle, per limb, per muscle and overall
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Number of muscles injected in ULS +/- LLS
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Reported reason for Dysport® injection and for change
Outcome will be assessed according following reasons: due to medical need, unplanned need and not recorded
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Number of Dysport® interruptions
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Reasons of Dysport® discontinuation
Outcome will be assessed according following reasons: side effects (e.g. excessive weakness, hematoma), contractures, absence of clinical response, long lasting clinical improvement, patient lost follow up and other.
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019).
Changes in Modified Ashworth Scale (MAS) scores by time period per muscle
The MAS is a six-point scale to grade muscle tone in the injected muscle from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). Upper limb: shoulder abduction, elbow flexion, elbow extension, wrist flexion, wrist extension and fingers flexion. Lower limb: hip flexion, hip adduction, hip abduction, knee flexion, knee extension, ankle dorsiflexion and ankle plantar flexion.
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Changes in Functional Independence Measure (FIM) subscales
Subscales and total scores of FIM will be measured. The FIM is a method for categorising patients on a seven-point scale (range 1 to 7). It comprises of 18 items, grouped into 2 subscales (motor and cognition). The motor subscale includes: eating, grooming, bathing, dressing upper body, dressing lower body, toileting, bladder management, bowel management, transfers - bed/chair/wheelchair, transfers - toilet, transfers - bath/shower, walk/wheelchair and stairs. The cognition subscale includes: comprehension, expression, social interaction, problem solving and memory. The Scores are summed to obtain a total score that can range between 18 and 126.
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Changes in Pain score according to pain Visual Analogue Scales (VAS)
The pain Visual Analogue Scale (VAS) is a numeric graphic rating scale (NGRS) of self-reported symptoms. Scores are recorded as whole numbers between zero and 10, where zero indicates no pain symptom at all, and 10 indicates a as bad as it could be.
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Gait pattern evaluation in patients with LLS
Gait Pattern Modification in patients with LLS is based on physician´s clinical evaluation and it will be evaluated for each lower limb (left and right) or both according to pre-specified patterns: equinismus, foot inversion, knee hyperextension, adduction, mowing abduction, thigh elevation, hip elevation, false trendelenburg, not able to walk. The Gait Pattern Improvement is described based on patient´s perception of gait. The patients respond Yes or No and if Yes the % of improvement is replied
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Concomitant drugs for the management of patients with ULS +/- LLS
List the systemic drug therapies, including: antispasticity medications (e.g. Baclofen, Tizanidin, Dantrolene), simple pain medications (e.g. paracetamol or NSAIDS), neuropathic pain and spasticity medications (e.g. Gabapentin, Pregabalin, Amitriptyline), opioids, phenol, alcool or other neurolytic agents.
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Non-drug concomitant therapies for the management of patients with ULS +/- LLS
List the non-drug concomitant therapies, including occupational therapy, physiotherapy and others (e.g.: orthotics, serial casting, splinting, electric stimulation)
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Incidence and intensity of Adverse Events
Adverse events will be assessed according to incidence, intensity/grade (mild, moderate and severe), causality (related and not related to the product), outcome (the overall association between an exposure to a drug and an outcome) and action taken. All Adverse Events (AEs) (including fatal events and Serious Adverse Events (SAEs)) and special situation (pregnancy, overdose, off-label use) will be reported with the number and proportion of events. The incidence will be provided and classified by System Organ Class and Preferred Term
Measured: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start5 Mar 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 200 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
- NCT04446702
- Sponsor's protocol ID
- A-BR-52120-269
- Acronym
- RETURN
- Status last verified
- Dec 2021
- First submitted
- 8 Jun 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Real-life Study From One Brazilian Reference Centre Assessing Long-term Experience in the Treatment of Adult Spasticity With AbobotulinumtoxinA (RETURN Study)
- ClinicalTrials.gov ID
- NCT04446702
- Acronym / sponsor ID
- RETURN / A-BR-52120-269
- Conditions
- Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 25 Jun 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 the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible adult patients having received Dysport® for at least three cycles for the treatment of ULS +/- LLS between January 1st, 2006 and July 31st, 2019 at Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil with pre- and post-injection effectiveness data available will be enrolled.
Key inclusion criteria (4 listed)
- Adult aged ≥18 years old at the time of the first Dysport® injection
- Diagnosed with spasticity
- Treated with a minimum of three Dysport® injection cycles for ULS +/- LLS in the observational period
- Follow up effectiveness data are available in the subject's medical record
Key exclusion criteria (3 listed)
- Patients have received previous treatment with another BoNT-A less than 12 weeks prior to the patient data collection in the study
- Adults with cerebral palsy
- Patients treated with BoNT-A in a clinical trial setting
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 injected during all sessions of Dysport® in ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Median total dose injected during all sessions of Dysport® in ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Average interval between Dysport® injections in ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
15 secondary outcomes
Baseline subjects characteristics
Time frame: Baseline (first Dysport® injection)
Total number of Dysport® injection cycles
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Total time exposure to Dysport® treatment in ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Total dose injected per cycle, per limb, per muscle and overall
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Number of muscles injected in ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Reported reason for Dysport® injection and for change
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Number of Dysport® interruptions
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Reasons of Dysport® discontinuation
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019).
Changes in Modified Ashworth Scale (MAS) scores by time period per muscle
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Changes in Functional Independence Measure (FIM) subscales
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Changes in Pain score according to pain Visual Analogue Scales (VAS)
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Gait pattern evaluation in patients with LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Concomitant drugs for the management of patients with ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Non-drug concomitant therapies for the management of patients with ULS +/- LLS
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Incidence and intensity of Adverse Events
Time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
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 16 Dec 2021.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Ipsen at 1 site in Brazil.
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 4 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 injected during all sessions of Dysport® in ULS +/- LLS (time frame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)). The study lists 3 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 16 Dec 2021.