Category: Pediatric Movement Disorders
Objective: To investigate the use of incobotulinumtoxinA in the treatment of lower limb spasticity in children and adolescents with cerebral palsy (CP).
Background: Spasticity associated with pediatric CP significantly impacts physical function and well-being, presenting ongoing challenges in clinical management and long-term care.
Method: This prospective, randomized, placebo-controlled, 28-week clinical trial consisted of two stages. 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 randomized 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 favorable safety and tolerability profile.
To cite this abstract in AMA style:
I. Makedonska. IncobotulinumtoxinA for the Treatment of Lower Limb Spasticity in Children and Adolescents with Cerebral Palsy Evaluation of Lower Limb IncobotulinumtoxinA Efficacy (ELLIE) [abstract]. Mov Disord. 2026; 41 (suppl 1). https://www.mdsabstracts.org/abstract/incobotulinumtoxina-for-the-treatment-of-lower-limb-spasticity-in-children-and-adolescents-with-cerebral-palsy-evaluation-of-lower-limb-incobotulinumtoxina-efficacy-ellie/. Accessed October 1, 2026.« Back to 2026 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/incobotulinumtoxina-for-the-treatment-of-lower-limb-spasticity-in-children-and-adolescents-with-cerebral-palsy-evaluation-of-lower-limb-incobotulinumtoxina-efficacy-ellie/