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Long-term incobotulinumtoxinA treatment for chronic sialorrhea : Efficacy and safety over 64 weeks. / Jost, Wolfgang H; Friedman, Andrzej; Michel, Olaf; Oehlwein, Christian; Slawek, Jaroslaw; Bogucki, Andrzej; Ochudlo, Stanislaw; Banach, Marta; Pagan, Fernando; Flatau-Baqué, Birgit; Dorsch, Ulrike; Csikós, János; Blitzer, Andrew.

In: Parkinsonism and Related Disorders, Vol. 70, 01.2020, p. 23-30.

Research output: Contribution to journalArticle

Harvard

Jost, WH, Friedman, A, Michel, O, Oehlwein, C, Slawek, J, Bogucki, A, Ochudlo, S, Banach, M, Pagan, F, Flatau-Baqué, B, Dorsch, U, Csikós, J & Blitzer, A 2020, 'Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks', Parkinsonism and Related Disorders, vol. 70, pp. 23-30. https://doi.org/10.1016/j.parkreldis.2019.11.024

APA

Jost, W. H., Friedman, A., Michel, O., Oehlwein, C., Slawek, J., Bogucki, A., ... Blitzer, A. (2020). Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism and Related Disorders, 70, 23-30. https://doi.org/10.1016/j.parkreldis.2019.11.024

Vancouver

Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A et al. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism and Related Disorders. 2020 Jan;70:23-30. https://doi.org/10.1016/j.parkreldis.2019.11.024

Author

Jost, Wolfgang H ; Friedman, Andrzej ; Michel, Olaf ; Oehlwein, Christian ; Slawek, Jaroslaw ; Bogucki, Andrzej ; Ochudlo, Stanislaw ; Banach, Marta ; Pagan, Fernando ; Flatau-Baqué, Birgit ; Dorsch, Ulrike ; Csikós, János ; Blitzer, Andrew. / Long-term incobotulinumtoxinA treatment for chronic sialorrhea : Efficacy and safety over 64 weeks. In: Parkinsonism and Related Disorders. 2020 ; Vol. 70. pp. 23-30.

BibTeX

@article{512e67057fa44addaed863095aa62616,
title = "Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks",
abstract = "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.",
keywords = "Botulinum toxin, Drooling, IncobotulinumtoxinA, Parkinson's disease/Parkinsonism, Sialorrhea",
author = "Jost, {Wolfgang H} and Andrzej Friedman and Olaf Michel and Christian Oehlwein and Jaroslaw Slawek and Andrzej Bogucki and Stanislaw Ochudlo and Marta Banach and Fernando Pagan and Birgit Flatau-Baqu{\'e} and Ulrike Dorsch and J{\'a}nos Csik{\'o}s and Andrew Blitzer",
note = "Copyright {\circledC} 2019. Published by Elsevier Ltd.",
year = "2020",
month = "1",
doi = "10.1016/j.parkreldis.2019.11.024",
language = "English",
volume = "70",
pages = "23--30",
journal = "Parkinsonism and Related Disorders",
issn = "1353-8020",
publisher = "Elsevier BV",

}

RIS

TY - JOUR

T1 - Long-term incobotulinumtoxinA treatment for chronic sialorrhea

T2 - Efficacy and safety over 64 weeks

AU - Jost, Wolfgang H

AU - Friedman, Andrzej

AU - Michel, Olaf

AU - Oehlwein, Christian

AU - Slawek, Jaroslaw

AU - Bogucki, Andrzej

AU - Ochudlo, Stanislaw

AU - Banach, Marta

AU - Pagan, Fernando

AU - Flatau-Baqué, Birgit

AU - Dorsch, Ulrike

AU - Csikós, János

AU - Blitzer, Andrew

N1 - Copyright © 2019. Published by Elsevier Ltd.

PY - 2020/1

Y1 - 2020/1

N2 - 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.

AB - 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.

KW - Botulinum toxin

KW - Drooling

KW - IncobotulinumtoxinA

KW - Parkinson's disease/Parkinsonism

KW - Sialorrhea

UR - http://www.scopus.com/inward/record.url?scp=85076230078&partnerID=8YFLogxK

U2 - 10.1016/j.parkreldis.2019.11.024

DO - 10.1016/j.parkreldis.2019.11.024

M3 - Article

C2 - 31794936

VL - 70

SP - 23

EP - 30

JO - Parkinsonism and Related Disorders

JF - Parkinsonism and Related Disorders

SN - 1353-8020

ER -

ID: 48579665