Session Information
Date: Thursday, November 14, 2019
Session Title: Neurological Rehabilitation Research Report
Session Time: 12:30pm-2:00pm
Location: Research Hub - Kiosk 6
Disclosures: Andreas Lysandropoulos: Ipsen: Employment
Objective: Review recent pivotal trial (Class I) evidence for botulinum toxins (BoNT) in adult and pediatric lower limb spasticity.
Design: Large (n=300-450), Phase III, double-blind, controlled studies.
Setting: International, multicenter studies conducted in specialist centers.
Participants: Adult studies: Hemiparetic adult patients with lower limb spasticity at the ankle joint due to stroke/TBI. Pediatric studies: Children (2-17 years) with dynamic equinus due to cerebral palsy.
Interventions: Adult doses were: AbobotulinumtoxinA 1000U & 1500U vs. placebo; OnabotulinumtoxinA 300-400U vs. placebo and IncobotulinumtoxinA 400U vs. placebo. Pediatric doses tested were: AboBoNT-A 10U/kg/leg & 15U/kg/leg vs. placebo; OnaBoNT-A 4U/kg/leg & 8 U/kg/leg vs. placebo and IncoBoNT-A. 6U/kg/leg & 8U/kg/leg vs. 2U/kg/leg.
Main Outcome Measures: All studies assessed muscle tone (primary) and Global Impression of Change (assessed as co-primary or key secondary) at peak effect (Week 4-6) and Week 12. Whereas the AboBoNT-A and OnaBoNT-A studies assessed muscle tone using the Modified Ashworth (MAS), the IncoBoNT-A studies used the Ashworth Scale (AS).
Results: Both AboBoNT-A and OnaBoNT-A achieved their primary endpoints in the adult and pediatric studies (significance vs. placebo was only shown for the higher 8U/kg/dose in the OnaBoNT-A pediatric study). Treatment with AboBoNT-A also consistently showed sustained improvement in MAS at Week 12. Results for the IncoBoNTA studies showed no significant differences on AS or Global Impression between IncoBoNT-A and placebo/low dose controls in the adult or pediatric lower limb spasticity studies. Safety profiles of the three BoNT-As were comparable.
Conclusions: Overall, these results reinforce the different efficacy profiles of AboBoNT-A, OnaBoNT-A and IncoBoNT-A as assessed in similarly designed (size/patient population/injection paradigm/outcome measures) registrational, Phase III clinical trials. The similarities and differences in the data presented above are important for clinicians to understand as they provide the basis for BoNT-A regulatory approval.
Level of Evidence: Level I
To cite this abstract in AMA style:
Lysandropoulos A, Picaut P. Differential Efficacy of Botulinum Toxin A in the Management of Adult and Pediatric Lower Limb Spasticity: Evidence from Phase III Clinical Studies [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/differential-efficacy-of-botulinum-toxin-a-in-the-management-of-adult-and-pediatric-lower-limb-spasticity-evidence-from-phase-iii-clinical-studies/. Accessed May 12, 2025.« Back to AAPM&R Annual Assembly 2019
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/differential-efficacy-of-botulinum-toxin-a-in-the-management-of-adult-and-pediatric-lower-limb-spasticity-evidence-from-phase-iii-clinical-studies/