• Wolfgang H Jost
  • Andrzej Friedman
  • Olaf Michel
  • Christian Oehlwein
  • Jaroslaw Slawek
  • Andrzej Bogucki
  • Stanislaw Ochudlo
  • Marta Banach
  • Fernando Pagan
  • Birgit Flatau-Baqué
  • Ulrike Dorsch
  • János Csikós
  • Andrew Blitzer

BACKGROUND: Botulinum neurotoxin (BoNT) is an effective treatment for chronic sialorrhea; however, reliable and robust evidence supporting long-term efficacy and safety is lacking. This study investigated the efficacy and safety of repeated incobotulinumtoxinA injections for chronic sialorrhea over 64 weeks.

METHODS: Adults with sialorrhea were randomized (2:2:1) to incobotulinumtoxinA 75 U, incobotulinumtoxinA 100 U (n = 74 each), or placebo (n = 36) in the double-blind, placebo-controlled main period (NCT02091739). Eligible subjects entered the extension period and received dose-blinded incobotulinumtoxinA 75 or 100 U in three further 16±2-week injection cycles. Efficacy and safety assessments in subjects who received incobotulinumtoxinA throughout the study included unstimulated salivary flow rate (uSFR), subjects' Global Impression of Change Scale (GICS), Drooling Severity and Frequency Scale (DSFS), modified Radboud Oral Motor Inventory for Parkinson's Disease (mROMP) drooling, speech, and swallowing symptom scores, and incidence of adverse events (AEs).

RESULTS: In total, 173/184 subjects (94%) completed the main period and entered the extension period; 141 subjects received incobotulinumtoxinA 75 U (n = 69) or 100 U (n = 72) in both periods. Mean uSFR decreased consistently with repeated incobotulinumtoxinA 75 and 100 U treatment and by -0.16 and -0.17, respectively, at the end-of-study visit. Subjects' GICS, DSFS, and mROMP drooling scores also improved at all assessments. mROMP speech and swallowing scores remained stable. The most common treatment-related AEs during the extension period were dry mouth (4.4% and 11.1%) and dysphagia (1.5% and 4.2%).

CONCLUSIONS: Data support long-term efficacy and safety of repeated incobotulinumtoxinA treatment for sialorrhea, with no additional safety concerns reported over 64 weeks.

Original languageEnglish
Pages (from-to)23-30
Number of pages8
JournalParkinsonism and Related Disorders
Volume70
Early online date26 Nov 2019
DOIs
Publication statusPublished - Jan 2020

    Research areas

  • Botulinum toxin, Drooling, IncobotulinumtoxinA, Parkinson's disease/Parkinsonism, Sialorrhea

ID: 48579665