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

Thursday, February 19, 2026

5:00 PM - 6:30 PM AST

Co-Author(s)

MB

Marta Banach, MD

Department of Neurology
Jagiellonian University
Krakow, Malopolskie, Poland
IM

Iryna Makedonska, MD

Department of Neurology
Dnipro City Pediatric Clinical Hospital
Dnipro, Dnipropetrovs'ka Oblast', Ukraine
VM

Veronika Mykhaylenko, MD

Head
Odessa Regional Charitable Rehabilitation Foundation for Handicapped Children “Futurum”
Odessa, Odes'ka Oblast', Ukraine
AH

Angelika Hanschmann, PhD

Lead Biostatistician
Merz Therapeutics GmbH
Frankfurt am Main, Hessen, Germany

Presenting Author(s)

AD

Andrzej Dekundy, MD

Senior Medical Expert, Global Clinical Science
Merz Therapeutics GmbH
Frankfurt am Main, Hessen, Germany

Submitter(s)

JL

Jennifer LoBraico

Jenny LoBraico
Raleigh, North Carolina, United States

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 for >50kg). Total body dose was 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.

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