Clinical trial NCT04446702: Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.


Eligibility criteria: 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

Primary outcomes:
measure: Average total dose injected during all sessions of Dysport® in ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Median total dose injected during all sessions of Dysport® in ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Average interval between Dysport® injections in ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Secondary outcomes:
measure: Baseline subjects characteristics
timeFrame: Baseline (first Dysport® injection)
measure: Total number of Dysport® injection cycles
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Total time exposure to Dysport® treatment in ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Total dose injected per cycle, per limb, per muscle and overall
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Number of muscles injected in ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Reported reason for Dysport® injection and for change
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Number of Dysport® interruptions
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Reasons of Dysport® discontinuation
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019).
measure: Changes in Modified Ashworth Scale (MAS) scores by time period per muscle
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Changes in Functional Independence Measure (FIM) subscales
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Changes in Pain score according to pain Visual Analogue Scales (VAS)
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Gait pattern evaluation in patients with LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Concomitant drugs for the management of patients with ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Non-drug concomitant therapies for the management of patients with ULS +/- LLS
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
measure: Incidence and intensity of Adverse Events
timeFrame: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)
Other outcomes:
Locations:
city: San Paolo
country: Brazil
facility: Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP)
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: