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Completed

NCT Number: NCT04446702

Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP)

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. Baseline subjects characteristics

    Time frame: Baseline (first Dysport® injection)

    • Demography (age at first injection during the period of interest, sex, weight)
    • History of spasticity
  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

    Outcome will be assessed according following reasons: due to medical need, unplanned need and not recorded

  7. 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)

  8. 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).

    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.

  9. 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)

    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.

  10. 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)

    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.

  11. 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)

    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.

  12. 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)

    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

  13. 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)

    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.

  14. 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)

    List the non-drug concomitant therapies, including occupational therapy, physiotherapy and others (e.g.: orthotics, serial casting, splinting, electric stimulation)

  15. 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)

    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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Retrospective Real-life Study From One Brazilian Reference Centre Assessing Long-term Experience in the Treatment of Adult Spasticity With AbobotulinumtoxinA (RETURN Study)

Acronym: RETURN

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
Dec 16, 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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