Session Information
Date: Friday, November 15, 2019
Session Title: Neurological Rehabilitation Research Report
Session Time: 12:30pm-2:00pm
Location: Research Hub - Kiosk 6
Disclosures: Alberto Esquenazi, MD, FAAPMR: Ipsen: Research Grant or Support
Objective: Report functional outcomes of repeat abobotulinumtoxinA (aboBoNT-A) injections from three Phase III open-label spasticity trials.
Design: Phase III, open-label extension studies in adult upper-limb (AULS; NCT01313312), lower-limb limb (ALLS; NCT01251367) and pediatric lower-limb (NCT01251380) spasticity.
Setting: International specialist centers
Participants: Adults with upper-limb or lower-limb limb spasticity post-stroke/traumatic brain injury and children with dynamic equinus due to cerebral palsy.
Interventions: AULS/ALLS: Adults (18–78 years) received aboBoNT-A (500–1500U) over 1 year. PLLS: Children (2–17 years) received aboBoNT-A (5–30 U/kg, total body weight) over 4 cycles at ≥12-week intervals.
Main Outcome Measures: In adults, active upper-limb function was assessed by Modified Frenchay Scale (MFS) and lower-limb limb function was assessed by 10-meter comfortable barefoot walking speed (CBWS). In children, functional gait was assessed using the Observational Gait Scale (OGS).
Results: 254 (AULS) and 345 (ALLS) adults and 207 children (PLLS) were enrolled and treated in open-label Cycle 1. In the AULS study, the mean±SD change in MFS from baseline to Week 4 post-injection was +0.21±0.53 in the double-blind phase reaching +0.51±0.80 at Open-label Cycle 2. In the ALLS study, CBWS (n=134) improved by +0.09±0.14 m/sec at Open-label Cycle 4 (mean 25% increase from double-blind baseline). In the PLLS study, Week-4 OGS improvements were maintained (+1.4±2.7 in double-blind phase and +1.4±3.2 in Open-label Cycle 3 (n=80)). Adult incidence of related treatment emergent adverse events (TEAEs) was low across cycles; 21 children had treatment-related TEAEs in the open-label phase, without evidence of a cumulative effect with repeat injections. TEAEs were not dose related.
Conclusions: AboBoNT-A was well tolerated following repeated injections in adult and pediatric patients, and TEAEs were consistent with previous clinical studies. These results contribute to a growing body of evidence to support use of aboBoNT-A to help improve active function in adults and children with chronic upper-limb or lower-limb-limb spasticity.
Level of Evidence: Level I
To cite this abstract in AMA style:
Esquenazi A, Gracies J, Picaut P, Grandoulier A, Delgado M. AbobotulinumtoxinA Improves Functional Outcomes After Single and Repeat Dosing in Adults and Children with Spasticity [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/abobotulinumtoxina-improves-functional-outcomes-after-single-and-repeat-dosing-in-adults-and-children-with-spasticity/. Accessed May 22, 2025.« Back to AAPM&R Annual Assembly 2019
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/abobotulinumtoxina-improves-functional-outcomes-after-single-and-repeat-dosing-in-adults-and-children-with-spasticity/