Efficacy of incobotulinumtoxinA in subjects with sialorrhea, assessed using the modified radboud oral motor inventory for Parkinson's disease (mROMP)

Abstract

Introduction: SIAXI (NCT02091739), a double‐blind, randomized, Phase 3 study, assessed the efficacy and safety of incobotulinumtoxinA in subjects with sialorrhea. Here, we report outcomes on modified Radboud Oral Motor Inventory for Parkinson's disease (mROMP) subscales. Methods: Subjects with sialorrhea due to Parkinson's disease, atypical parkinsonism, stroke, or traumatic brain injury were randomized (2:2:1) to incobotulinumtoxinA 75 or 100 U, or placebo distributed in bilateral parotid and submandibular glands in a single injection cycle (16±2 weeks duration). The change from baseline in drooling, speech, and swallowing symptoms was assessed using mROMP. At screening, baseline, 4, 8, 12, and 16 weeks post‐treatment, subjects rated 24 items on a 5‐point Likert scale from 1 (normal) to 5 (worst score) based on their recollection of the last 7 days (Arch Phys Med Rehabil 2011). Results: Subjects (N=184) were randomized to incobotulinumtoxinA 75 U (n=74), 100 U (n=74), or placebo (n=36); 173 subjects completed the main period. mROMP drooling scores improved from baseline to all post‐treatment visits in both active treatment groups vs placebo. In the incobotulinumtoxinA 75 U, 100 U, and placebo groups, respectively, the greatest mean (standard deviation) improvements were at Week 8 (–6.29 [6.52], –6.58 [5.90], and –1.26 [4.91]) and 12 (–6.77 [6.05], –6.40 [5.20], and –1.77 [4.54]) post‐treatment. Mean mROMP speech symptom scores improved at all post‐treatment visits with no obvious differences between groups. There was no worsening in mean mROMP swallowing symptoms. Conclusions: IncobotulinumtoxinA resulted in clinically relevant improvement in subjects with sialorrhea. Funding: Merz Pharmaceuticals GmbH Keywords: IncobotulinumtoxinA; Parkinson's disease; Sialorrhea; Stroke Reference Kalf JG, Borm GF, de Swart BJ, Bloem BR, Zwarts MJ, Munneke M. Reproducibility and validity of patient‐rated assessment of speech, swallowing, and saliva control in Parkinson's disease. Arch Phys Med Rehabil. 2011;92(7):1152‐1158.