Wolfgang H Jost1, Andrzej Friedman2, Olaf Michel3, Christian Oehlwein4, Jaroslaw Slawek5, Andrzej Bogucki6, Stanislaw Ochudlo7, Marta Banach8, Fernando Pagan9, Birgit Flatau-Baqué10, Ulrike Dorsch11, János Csikós12, Andrew Blitzer13. 1. Parkinson-Klinik Ortenau, Wolfach, Germany. Electronic address: w.jost@parkinson-klinik.de. 2. Department of Neurology, Faculty of Health Science, Medical University of Warsaw, Warsaw, Poland. Electronic address: andrzej.friedman@wum.edu.pl. 3. Department of Otorhinolaryngology, University Hospital Brussels, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address: omichel@uzbrussel.be. 4. Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation, Gera, Germany. Electronic address: parkinson@oehlwein.com. 5. Department of Neurological-Psychiatric Nursing, Medical University of Gdansk, Gdansk, Poland; Neurology Department, St Adalbert Hospital, Gdansk, Poland. Electronic address: jaroslaw.slawek@gumed.edu.pl. 6. Department of Extrapyramidal Diseases, Medical University of Łódź, Łódź, Poland. Electronic address: andrzej.bogucki@umed.lodz.pl. 7. Department of Neurology and Stroke Unit, Medical University of Silesia, Katowice, Poland. Electronic address: stanislaw.ochudlo@op.pl. 8. Department of Neurology, Collegium Medicum, Jagiellonian University Medical College, Krakow, Poland. Electronic address: martabanach@yahoo.com. 9. Department of Neurology, Georgetown University Hospital, Washington DC, USA. Electronic address: FPOGAN01@gunet.georgetown.edu. 10. Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Electronic address: Birgit.Flatau-Baque@merz.de. 11. Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Electronic address: Ulrike.Dorsch@merz.de. 12. Formerly of Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Electronic address: janoscsikos@gmx.at. 13. Department of Otolaryngology/Head and Neck Surgery, Columbia University College of Physicians and Surgeons, New York, NY, USA; Department of Neurology, Icahn School of Medicine at Mt. Sinai, New York, NY, USA; NY Center for Voice and Swallowing Disorders, New York, NY, USA. Electronic address: ab1136@aol.com.
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 receivedincobotulinumtoxinA 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 receivedincobotulinumtoxinA 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 mROMPdrooling 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.
RCT Entities:
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.