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

NCT ID: NCT04446702

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-05

Study Completion Date

2021-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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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

Site Status

Countries

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Brazil

Other Identifiers

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A-BR-52120-269

Identifier Type: -

Identifier Source: org_study_id