Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity

Purpose

The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).

Condition

  • Lower Limb Spasticity

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female or male subjects aged 2 to 17 years inclusive - Decision to prescribe abobotulinumtoxinA, to be made prior to and independently from the decision to enroll in the study - Primary diagnosis of paediatric lower limb (PLL) spasticity and either: Previously untreated with BoNT (naïve to BoNT), or previously treated with a BoNT (i.e. non naïve to BoNT), and for those who were previously treated with BoNT-A, they should have responded to BoNT-A treatment according to the investigator's criteria - For non naïve BoNT subjects, a minimum interval of 12 weeks since the last BoNT injection and in the presence of spasticity

Exclusion Criteria

  • Known resistance to any BoNT or experienced serious safety issues with previous use of BoNT - Concomitant treatment with other BoNT - Known hypersensitivity to abobotulinumtoxinA or related compounds, or any component in the study drug formulation - Subjects with any clinical (or subclinical) evidence of marked defective neuromuscular transmission (e.g. Lambert Eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

More Details

Status
Completed
Sponsor
Ipsen

Study Contact