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Final Program


Final Congress Guide

Clinical Sciences/Health Conditions

400 Section - IncobotulinumtoxinA for the Treatment of Lower Limb Spasticity in Children and Adolescents with Cerebral Palsy: Evaluation of Lower Limb IncobotulinumtoxinA Efficacy (ELLIE)

Tuesday, May 19, 2026
6:00 PM - 7:30 PM PT
Objectives : Spasticity associated with paediatric cerebral palsy (CP) significantly impacts physical function and well-being. This prospective, randomised, placebo-controlled, two-stage, double-blind, multicentre, 28-week clinical trial investigated incobotulinumtoxinA in the treatment of lower limb spasticity in children and adolescents with CP.

Design: Double-blind cycle 1: patients aged 2–17 years with bilateral lower limb spasticity received intramuscular injections of incobotulinumtoxinA (8 U/kg body weight [BW]; max 400 U for >50kg) for plantar flexors in one leg and placebo in the other, using identical treatment plans. Open-label cycle 2: patients received bilateral incobotulinumtoxinA (8 U/kg BW, max 200 U/leg; total body dose 16 U/kg BW for ≤25kg BW; max 400 U for >25kg).  The primary endpoint was change in derived Modified Ashworth Scale (MAS) score of plantar flexors. Secondary endpoints were MAS response, Goal Attainment Scale (GAS)-T score and Global Impression of Change in Plantar Flexors (GICS-PF).

Results:

Of 131 randomised patients, 60.3% were male and 49.6% were aged 6–11 years. IncobotulinumtoxinA significantly improved derived MAS scores of plantar flexors versus placebo at Weeks 4 and 6 (adjusted effect estimate [95% confidence interval] -0.36; [-0.60, -0.12]; p=0.002). Response rates were higher with incobotulinumtoxinA at Week 4 or 6 versus placebo (76.7% versus 62.8%; p< 0.05). GICS-PF and GAS-T scores were significantly higher (p< 0.05) with incobotulinumtoxinA versus placebo at Weeks 4 and 6. No safety concerns were observed with incobotulinumtoxinA.

Conclusion:

: Lower limb spasticity in children and adolescents with CP significantly improved with incobotulinumtoxinA, with a favourable safety and tolerability profile.