Trial reportNeurology2019
SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea.
Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02091739 (Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions), which is not on this map. Cited by 54 papers, 4 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 4 pooled it
6.4field-weighted citation impact, top 2% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
Who cites it
54 citing papers in PubMed, 4 syntheses or guidelines pooled it, 115 citations in OpenAlex.
- Effectiveness of the pharmacological treatments for sialorrhea in patients with Parkinson's disease: a systematic review and network meta-analysis.Clinical oral investigations · 2023Pooled it
- Oral health effects of botulinum toxin treatment for drooling: a systematic review.Medicina oral, patologia oral y cirugia bucal · 2021Pooled it
- A comprehensive review of the diagnosis and treatment of Parkinson's disease dysphagia and aspiration.Expert review of gastroenterology & hepatology · 2020Pooled it
- Hypersalivation: update of the German S2k guideline (AWMF) in short form.Journal of neural transmission (Vienna, Austria : 1996) · 2019Guideline
- Nurse-led management of sialorrhea in Parkinson's disease: a pilot randomized controlled trial.Frontiers in medicine · 2026Trial
- Efficacy and Safety of IncobotulinumtoxinA for Treatment of Sialorrhea: A Multicenter, Phase 3 Study in Japan.Movement disorders clinical practice · 2026Trial
- Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.JAMA neurology · 2020Trial
- Review
- IncobotulinumtoxinA Injection to Balance Eyebrows and Facial Shapes: A Review with Illustrative Clinical Examples.Toxins · 2026Review
- Botulinum toxin for chronic migraine.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- Article
- Article
- Feasibility and structure of a state hospital botulinum neurotoxin clinic for clozapine-induced sialorrhea.Annals of general psychiatry · 2025Article
- Long-Term Safety and Efficacy of Repeated Cycles of RimabotulinumtoxinB in the Treatment of Chronic Sialorrhea: Results of the OPTIMYST Trial.Neurology and therapy · 2025Article
- Preventive Effects of Botulinum Neurotoxin Long-Term Therapy: Comparison of the 'Experienced' Benefits and 'Suspected' Worsening Across Disease Entities.Journal of clinical medicine · 2025Article
- The use of Botulinum Toxin Type A in patients in out-of-hospital intensive care in Germany-results from a multidisciplinary online survey.Frontiers in neurology · 2025Article
- Effects of focal low energy extracorporeal shock wave treatment on reduction of sialorrhea in Parkinson's disease.Frontiers in neurology · 2025Article
- The diagnosis comes before therapy, even with non-motor features.Therapeutic advances in neurological disorders · 2025Article
- Management of Gastrointestinal Symptoms in Parkinson's Disease.Journal of central nervous system disease · 2025Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Wolfgang H JostFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY. w.jost@parkinson-klinik.de.
Andrzej FriedmanFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Olaf MichelFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.ORCID 0000-0003-4289-5693
Christian OehlweinFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Jaroslaw SlawekFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Andrzej BoguckiFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Stanislaw OchudloFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Marta BanachFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Fernando PaganFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Birgit Flatau-BaquéFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
János CsikósFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Claire J CairneyFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Andrew BlitzerFrom the Parkinson-Klinik Ortenau (W.H.J.), Wolfach, Germany; Department of Neurology (A.F.), Faculty of Health Science, Medical University of Warsaw, Poland; Department of Otorhinolaryngology (O.M.), University Hospital Brussels, Vrije Universiteit Brussel, Belgium; Neurological Outpatient Clinic for Parkinson's Disease and Deep Brain Stimulation (C.O.), Gera, Germany; Department of Neurological-Psychiatric Nursing (J.S.), Medical University of Gdansk; Neurology Department (J.S.), St. Adalbert Hospital, Gdansk; Department of Extrapyramidal Diseases (A. Bogucki), Medical University of Łódź; Department of Neurology and Stroke Unit (S.O.), Medical University of Silesia, Katowice; Department of Neurology (M.B.), Collegium Medicum, Jagiellonian University, Krakow, Poland; Department of Neurology (F.P.), Georgetown University Hospital, Washington, DC; Merz Pharmaceuticals GmbH (B.F.-B., J.C.), Frankfurt am Main, Germany; Complete Medical Communications (C.J.C.), Glasgow, UK; Department of Otolaryngology/Head and Neck Surgery (A. Blitzer), Columbia University College of Physicians and Surgeons, New York; Department of Neurology (A. Blitzer), Icahn School of Medicine at Mt. Sinai, New York; and NY Center for Voice and Swallowing Disorders (A. Blitzer), New York, NY.
Parkinson-Klinik Ortenau · DE
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis pivotal phase III study, SIAXI, investigated the efficacy and safety of incobotulinumtoxinA for the treatment of chronic sialorrhea due to Parkinson disease (PD), atypical parkinsonism, stroke, or traumatic brain injury (TBI).
methodsAdult patients with PD (70.7%), atypical parkinsonism (8.7%), stroke (19.0%), or TBI (2.7%) were randomized (2:2:1) to double-blind treatment with placebo (n = 36), or total doses of incobotulinumtoxinA 75 U (n = 74) or 100 U (n = 74), in a single treatment cycle. The coprimary endpoints were change in unstimulated salivary flow rate from baseline to week 4, and patients' Global Impression of Change Scale score at week 4. Adverse events were recorded throughout.
resultsA total of 184 patients were randomized. Both incobotulinumtoxinA dose groups showed reductions in mean unstimulated salivary flow rate at week 4, with a significant difference vs placebo in the incobotulinumtoxinA 100 U group (
conclusionsIncobotulinumtoxinA 100 U is an effective and well-tolerated treatment of chronic sialorrhea in adults. CLINICALTRIALSGOV IDENTIFIER: NCT02091739. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that incobotulinumtoxinA reduces salivary flow rates in patients with chronic sialorrhea due to PD, atypical parkinsonism, stroke, or TBI.
Indexed as
AgedBotulinum Toxins, Type ABrain Injuries, TraumaticDouble-Blind MethodFemaleHumansMaleMiddle AgedParkinson DiseaseSialorrheaStrokeTreatment OutcomeBotulinum Toxins, Type AincobotulinumtoxinA
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Registered trials
NCT02091739ClinicalTrials.gov
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