Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity
