Category: Pediatric Movement Disorders
Objective: Assess efficacy and safety of incobotulinumtoxinA in lower-limb (LL) or combined LL/upper-limb (LL/UL) spasticity in children and adolescents with cerebral palsy (CP).
Background: Ambulant or non‑ambulant, pre-treated or treatment-naïve subjects (age 2−17 years) with LL or LL/UL spasticity due to CP were assessed in two phase III studies; a lead-in prospective, double-blind, randomized study (TIM) followed by an open-label, non-controlled study (TIMO).
Method: TIM had three parallel dose groups (4 U/kg body weight (BW), 12 U/kg BW, 16 U/kg BW); subjects were randomized in a 1:1:2 ratio and received 2 double-blind injection cycles. In TIMO, subjects who had completed TIM, or newly recruited treatment-naïve or pre-treated subjects, received 4 injection cycles with the highest dose of TIM. The primary endpoints of TIM were change from baseline in Ashworth Scale (AS) of the plantar flexors (PF) score at Week 4 of Cycle 1, and the Investigator’s Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) score at Week 4 of Cycle 1. TIMO was focused on safety, and did not have primary efficacy endpoints.
Results: In TIM, all 3 dose groups experienced a statistically significant improvement in AS-PF score 4 weeks post-injection versus baseline. In TIMO, cumulative improvements in AS scores for the PF, knee flexors and thigh adductors were observed from TIM baseline to 4 weeks post-injection. Investigator’s GICS-PF scores indicated a positive response to treatment in all dose groups 4 weeks post-injection in TIM Cycle 1 and improvements were maintained in all treatment groups in Cycle 2. Respective clinical assessments also confirmed consistent improvement in LL and UL spasticity at Week 4 in all TIMO injection cycles. Both studies had good overall safety profiles.
Conclusion: IncobotulinumtoxinA at total doses up to 16–20 U/kg is effective and well tolerated for the multi-level, multi-pattern treatment of LL/UL spasticity due to CP in children and adolescents.
To cite this abstract in AMA style:
E. Dabrowski, H. Chambers, F. Heinen, P. Kaňovský, S. Schroeder, M. Banach, H. Dersch, T. Geister, F. Martinez-Torres, I. Pulte, D. Gaebler-Spira. Multi-level and multi-pattern lower- and upper-limb spasticity treatment with incobotulinumtoxinA in children and adolescents with cerebral palsy [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/multi-level-and-multi-pattern-lower-and-upper-limb-spasticity-treatment-with-incobotulinumtoxina-in-children-and-adolescents-with-cerebral-palsy/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2020
MDS Abstracts - https://www.mdsabstracts.org/abstract/multi-level-and-multi-pattern-lower-and-upper-limb-spasticity-treatment-with-incobotulinumtoxina-in-children-and-adolescents-with-cerebral-palsy/