Objective: The pivotal double-blind, randomised Phase III SIAXI study (NCT02091739), assessed the efficacy and safety of incobotulinumtoxinA 75 or 100 U for sialorrhea. Co-primary endpoints of the placebo-controlled main period (MP) are presented elsewhere. Here we report MP data from the modified Radboud Oral Motor Inventory for Parkinson’s disease (mROMP) subscales.

Background: Uncontrolled sialorrhea is a troublesome and disabling symptom associated with Parkinson’s disease (PD) and various other neurological conditions.

Methods: Adult patients with chronic, troublesome sialorrhea due to PD, atypical parkinsonism, stroke or traumatic brain injury were randomised (2:2:1) to receive 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 three domains (drooling, speech and swallowing symptoms) was assessed using the mROMP. At screening, baseline, 4, 8, 12 and 16 weeks post-treatment, patients 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 (Kalf JG, Arch Phys Med Rehabil 2011).

Results: 184 patients (mean [SD]) age 65.2 [11.4] years; 70.7% male; 70.7% with sialorrhea due to PD) were randomised and received either incobotulinumtoxinA 75 U (n=74), 100 U (n=74) or placebo (n=36); 173 patients completed the MP. Baseline demographics were similar in all groups. mROMP drooling scores improved from baseline to all post-treatment visits to a greater extent in both active treatment groups versus placebo. In the incobotulinumtoxinA 75 U, 100 U and placebo groups, respectively, the greatest mean [SD] improvements from baseline were at Weeks 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 slightly from baseline to all post-treatment visits with no obvious differences between groups. There was no worsening from baseline in mean mROMP swallowing symptoms. The mean (SD) change from baseline to Week 4 was –0.1 (3.1), –0.8 (2.4) and 0.3 (2.1), respectively.

Conclusions: IncobotulinumtoxinA resulted in clinically relevant improvement in patients with sialorrhea due to neurological causes.

References: 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):1152-8.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-incobotulinumtoxina-in-patients-with-sialorrhea-as-assessed-using-the-modified-radboud-oral-motor-inventory-for-parkinsons-disease-mromp-results-of-the-siaxi-study/