IncobotulinumtoxinA significantly reduces upper-limb spastic
This randomized, phase 3 study assessed incobotulinumtoxinA safety and efficacy for pediatric upper-limb spasticity treatment in ambulant/non-ambulant (Gross Motor Function Classification System [GMFCS] I–V) patients, with the option of combined upper- and lower-limb treatment.

Patients were aged 2–17 years with uni- or bilateral spastic cerebral palsy (CP) and Ashworth Scale (AS) score more than 2 in treatment-selected clinical patterns. In the MP, patients were randomized (2:1:1) to incobotulinumtoxinA 8, 6, or 2 U/kg body weight, with optional lower-limb injections in one of five topographical distributions. In the OLEX, patients received three further treatment cycles; doses per 8 U/kg/upper limb group. Outcomes included AS, Global Impression of Change Scale (GICS), and adverse events (AEs).

--AS scores improved from baseline to Week 4 in all MP dose groups (n=350); patients in the incobotulinumtoxinA 8 U/kg group had significantly greater spasticity improvements versus the 2 U/kg group.

--Investigator’s, child/adolescent’s and parent/caregiver’s GICS scores showed improvements in all groups.

--Treatment benefits were sustained over further treatment cycles. AE incidence did not increase with dose or repeated treatment across GMFCS levels.

In conclusion, multi-pattern incobotulinumtoxinA therapy showed long-term effectiveness and protection in children and adolescents with upper-limb spasticity.