Session Information
Date: Tuesday, June 21, 2016
Session Title: Spasticity
Session Time: 12:30pm-2:00pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To assess the efficacy and safety of incobotulinumtoxinA for upper-limb post-stroke spasticity.
Background: Botulinum toxin injections are a recommended therapy for limb spasticity. We report data from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA (Elovic et al. Muscle Nerve 2015 [in press]) with a 36-week, open-label extension (OLEX) period.
Methods: In the placebo-controlled main period (MP), adults (18-80 years of age) with upper-limb post-stroke spasticity (wrist, finger and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each with 12-week observations. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a patient-selected principal target domain [hygiene, dressing, limb position or pain] from study baseline to 4 weeks post-injection), adverse events (AEs) and antibody testing.
Results: Of 317 patients randomized in the MP, 296 continued into the OLEX. In the MP and OLEX, AS responder rates after each incobotulinumtoxinA treatment were 52.3-61.8% for wrist flexors, 49.1-60.0% for elbow flexors, 54.5-64.5% for finger flexors, 33.9-41.2% for thumb flexors and 37.4-44.2% for forearm pronators. Post-injection DAS responder rates for the principal target domain were 46.2% (MP), and 52.2%, 62.1% and 59.4% (OLEX injection cycles). During the MP, treatment-related AEs were reported in 3.8% and 1.9% of patients receiving incobotulinumtoxinA and placebo, respectively. During the entire 36-week OLEX, the treatment-related AE incidence was 3.0%. No serious treatment-related AEs and no clinical non-responsiveness due to antibodies occurred in the MP or the OLEX.
Conclusions: For patients with upper-limb post-stroke spasticity, repeated incobotulinumtoxinA injections (400U each at 12-week intervals) demonstrated sustained efficacy in reducing muscle tone and spasticity-associated disability. The study confirmed the favorable safety profile of incobotulinumtoxinA in this indication.
68th American Academy of Neurology Annual Meeting (15-21 April 2016).
To cite this abstract in AMA style:
P. Kanovský, A. Brashear, E.P. Elovic, M.C. Munin, A. Hanschmann, R. Hiersemenzel, C. Marciniak. A phase 3, placebo-controlled study with an open-label extension: Sustained incobotulinumtoxinA efficacy in upper-limb post-stroke spasticity over 48 weeks [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/a-phase-3-placebo-controlled-study-with-an-open-label-extension-sustained-incobotulinumtoxina-efficacy-in-upper-limb-post-stroke-spasticity-over-48-weeks/. Accessed November 22, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-phase-3-placebo-controlled-study-with-an-open-label-extension-sustained-incobotulinumtoxina-efficacy-in-upper-limb-post-stroke-spasticity-over-48-weeks/