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

Ipsen

Status: Completed

Conditions: Lower Limb Spasticity

Treatments: Biological: Botulinum toxin type A

Study type: Observational

Funder types: Industry

Identifiers

NCT03017729

A-US-52120-330

Details and patient eligibility

About

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).

Enrollment: 242 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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