AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Brazil

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.

  1. 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)

  2. 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)

  3. 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)
  1. Baseline subjects characteristics

    • Demography (age at first injection during the period of interest, sex, weight)
    • History of spasticity

    Measured: Baseline (first Dysport® injection)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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).

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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.

  1. First posted25 Jun 2020
  2. Study start5 Mar 2021
  3. Primary completion10 Dec 2021
  4. Study completion10 Dec 2021

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in