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

Ipsen242 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

242

Conditions

Lower Limb Spasticity

Interventions

Botulinum toxin type ABIOLOGICAL

This is an observational study designed to reflect real world clinical practice in the use of abobotulinumtoxinA. AbobotulinumtoxinA injected doses, frequency of injections, number of injection sites and volume injected per site are in accordance with the current USPI and physician's clinical practice.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

Cumulated GAS T score

Defined as the mean of the individual GAS T scores across all cycles will be used to measure progress towards individual therapy goals. If all goals are achieved as expected, the GAS T score is 50.0.

Time frame: From day 1 up to 30 months