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

NCT04446702 | Completed

• 1 other identifier: A-BR-52120-269
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity

Outcome Measures

Primary Outcomes (3)

• Average total dose injected during all sessions of Dysport® in ULS +/- LLS

  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

  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

  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

  Baseline (first Dysport® injection)

• Total number of Dysport® injection cycles

  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

  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

  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

  From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 25, 2020
• Study Start: March 5, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

BR (1)