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Cochrane Database Syst Rev 2020 11 12;11:CD003633. Epub 2020 Nov 12.

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.

Background: This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia, and is a highly disabling movement disorder, characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. Read More

J Neurol Sci 2020 09 9;416:117015. Epub 2020 Jul 9.

Ipsen Pharma, Boulogne-Billancourt, France.

Objective: Patients with cervical dystonia (CD) require regular injections of botulinum neurotoxin type A (BoNT-A) to maintain treatment effectiveness. In this secondary analysis of a large routine-practice study, we assessed the response to abobotulinumtoxinA over repeated cycles and compared the responses of patients previously naïve to BoNT treatment to those already treated with BoNT-A.

Methods: INTEREST IN CD2 was a prospective, 3-year, observational study following CD patients treated with BoNT-A. Read More

Parkinsonism Relat Disord 2020 01 26;70:23-30. Epub 2019 Nov 26.

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:

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). Read More

Neurol Ther 2019 Dec 21;8(2):273-288. Epub 2019 Sep 21.

Walton Centre NHS Foundation Trust, Liverpool, UK.

Botulinum neurotoxin (BoNT) is considered the treatment of choice for various symptoms and diseases such as focal dystonia and focal spasticity. The effects of BoNT on the salivary glands have also been known for years, but their use was limited because of a lack of approval studies. Now the indication of sialorrhea is approved in some countries for incobotulinumtoxinA, such as the USA and Europe, and therapy could also become the treatment of choice. Read More

Neurology 2019 04 27;92(17):e1982-e1991. Epub 2019 Mar 27.

From 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.

Objective: This 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).

Methods: Adult patients with PD (70.7%), atypical parkinsonism (8. Read More

J Neural Transm (Vienna) 2019 Feb 2;126(2):141-148. Epub 2019 Jan 2.

Movement Disorders Section, Department of Neurology, Hannover Medical School, Hannover, Germany.

Oromandibular dystonia (OMD) is a focal dystonia involving the mouth, jaw, and tongue. Botulinum neurotoxin (BoNT) therapy might be one form of treatment in OMD. Systematic pooling of BoNT studies in OMD remains wanting, as the derived data could provide useful information in regard to efficacy and safety issues. Read More

Dev Med Child Neurol 2018 11 26;60(11):1172-1177. Epub 2018 Aug 26.

Sydney Children's Hospital, Randwick, NSW, Australia.

Aim: To identify factors that increase the likelihood of systemic adverse events after botulinum neurotoxin A (BoNT-A) injections in children with cerebral palsy (CP).

Method: A prospective observational study of patients attending a BoNT-A clinic at a tertiary paediatric hospital (2010-2014). Occurrences of systemic adverse events, defined as lower respiratory tract illnesses, generalized weakness, dysphagia, and death were determined at follow-up. Read More

Medicine (Baltimore) 2018 Aug;97(34):e10659

Department of Poisoning Treatment, Affiliated Hospital, Academy of Military Medical Science, Poisoning Treatment Center of the Army, Beijing, China.

This study was conducted to analyze the clinical characteristics of and treatment strategies for botulism among patients receiving cosmetic injection of botulinum toxin (BoNT).A total of 86 botulism patients caused by cosmetic injection of BoNT were enrolled in our study. All of the patients were diagnosed according to their history of cosmetic BoNT injection, clinical symptoms and signs, and other auxiliary examinations (including those on renal and liver functions, blood index detection, and chest X-ray). Read More

Rev Neurol 2018 Jun;66(11):368-372

Hospital Clinico Universitario Lozano Blesa, 50009 Zaragoza, Espana.

Aim: To describe our experience in the treatment of laryngeal dystonia (in abduction and adduction), with special emphasis given to the technical aspects (approach procedure, dosage and type of botulinum toxin type A used), as well as treatment response and possible side effects.

Patients And Methods: We conducted a cross-sectional descriptive study of a sample of patients with laryngeal dystonia treated by means of transoral administration of onabotulinumtoxinA or incobotulinumtoxinA over a period of 10 years (2007-2017). Data collected include demographic and clinical variables, treatment response (based on a self-rating scale), the duration of treatment and the appearance of side effects. Read More

Basic Clin Pharmacol Toxicol 2018 Nov 21;123(5):622-627. Epub 2018 Jun 21.

Department of Medical and Toxicological Critical Care, Lariboisière Hospital, INSERM UMRS-1144, Paris-Diderot University, Paris, France.

Iatrogenic botulism resulting from the substantial increase in use of botulinum neurotoxin type A (BoNT-A) treatment is rarely reported. We aimed to describe a large iatrogenic botulism outbreak in Egypt in June-July 2017. Nine patients developed botulism after receiving intramuscular injections of BoNT-A (dose: 200-300 IU) to treat cerebral palsy (N = 7), spastic dystonia (N = 1) and hyperhidrosis (N = 1). Read More

Toxins (Basel) 2018 05 16;10(5). Epub 2018 May 16.

Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul 03080, Korea.

We aimed to evaluate the efficacy and safety of injecting botulinum toxin A (BoNT-A) into the neck muscles to treat cervical dystonia (CD) in patients with dyskinetic cerebral palsy (CP). This was a randomized, double-blinded, placebo-controlled trial with cross-over design. We prospectively enrolled adults with dyskinetic CP who were over 20 years old and had been clinically diagnosed with CD for more than one year. Read More

Dev Med Child Neurol 2018 05 16;60(5):498-504. Epub 2018 Feb 16.

The Children's Hospital at Westmead, Westmead, NSW, Australia.

Aim: To determine the incidence of common adverse events after botulinum toxin A (BoNT-A) injections in children with cerebral palsy (CP) and to identify whether the severity of CP influences the incidence of adverse events.

Method: This was an observational study of patients attending a BoNT-A clinic at a tertiary paediatric hospital (2010-2014). Data examined included procedural adverse events at the time of injection and at follow-up. Read More

Neurology 2018 02 17;90(7):e559-e564. Epub 2018 Jan 17.

From the Department of Neurology (W.G.O., M.H.S., V.H.), Methodist Neurological Institute, Houston, TX; Department of Neurology (W.G.O.), Weill Cornell Medical School, New York, NY; Parkinson's Disease Center and Movement Disorders Clinic (C.H., J.J.), Department of Neurology, Baylor College of Medicine; and Comprehensive Sleep Medicine Associates (J.H.S.), Sleep Title Education Consortium, Houston, TX.

Objectives: To test the safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism.

Methods: Participants 18 to 85 years old with clinically diagnosed sleep bruxism confirmed by polysomnography were enrolled in this randomized, placebo-controlled, 1:1, parallel-design trial with open-label extension. Participants were injected with BoNT-A 200 units (60 into each masseter and 40 into each temporalis) or placebo and were evaluated at 4 to 8 weeks after the initial treatment visit. Read More

Cochrane Database Syst Rev 2017 12 12;12:CD003633. Epub 2017 Dec 12.

Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz, Lisboa, Portugal, 1649-028.

Background: This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia and is a highly disabling movement disorder characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. Read More

J Neurol Sci 2017 Sep 24;380:142-147. Epub 2017 Jul 24.

Department of Otorhinolaryngology-Head and Neck Surgery, Turku University Hospital and University of Turku, Turku, Finland.

Objectives: Oropharyngeal dysphagia is a disabling and undertreated symptom that often occurs in patients with sporadic inclusion body myositis (s-IBM). In this study, we examined the effect of botulinum neurotoxin A (BoNT-A) injections to the cricopharyngeus muscle (CPM) of patients with s-IBM and dysphagia.

Patients, Materials And Methods: A single-center retrospective study involving 40 biopsy-proven s-IBM-patients treated in the District of Southwest Finland from 2000 to 2013. Read More

Curr Treat Options Neurol 2017 Aug 17;19(10):33. Epub 2017 Aug 17.

Yale University, New Haven, CT, 06520, USA.

Purpose of review The purpose of this review is to provide updated information on the role of botulinum neurotoxin (BoNT) therapy in multiple sclerosis (MS). This review aims to answer which symptoms of multiple sclerosis may be amenable to BoNT therapy. Recent findings We searched the literature on the efficacy of BoNTs for treatment of MS symptoms up to April 1st 2017 via the Yale University Library's search engine including but not limited to Pub Med and Ovis SP. Read More

Front Pharmacol 2017 22;8:80. Epub 2017 Feb 22.

Department of Neurophysiopathology, National Neurological Institute "C. Mondino" (IRCCS)Pavia, Italy; Department of Brain and Behavioral Sciences, University of PaviaPavia, Italy.

Neurogenic dysphagia linked to failed relaxation of the upper esophageal sphincter (UES) can be treated by injecting botulinum toxin (BTX) into the cricopharyngeal (CP) muscle. We compared the effects of this treatment in different neurological disorders with dysphagia, to evaluate its efficacy over time including the response to a second injection. Sixty-seven patients with neurogenic dysphagia associated with incomplete or absent opening of the UES (24 with brainstem or hemispheric stroke, 21 with parkinsonian syndromes, 12 with multiple sclerosis, and 10 with spastic-dystonic syndromes secondary to post-traumatic encephalopathy) were treated with the injection of IncobotulinumtoxinA (dose 15-20 U) into the CP muscle under electromyographic guidance. Read More

Eur J Phys Rehabil Med 2017 Oct 6;53(5):798-801. Epub 2017 Mar 6.

Department of Neurosciences and Sense Organs, AO Padua, Padua, Italy.

Background: Wallenberg's syndrome (WS) is known as posterior inferior cerebellar artery syndrome. Dysphagia has been reported from 51% to 94% of the patients, ranging from mild to severe.

Case Report: We reported a case of a patient (male; 52 years) with WS. Read More

Dev Med Child Neurol 2017 05 30;59(5):531-537. Epub 2016 Nov 30.

Department of Neurology, Donders Centre for Neuroscience, Radboud University Medical Centre, Nijmegen, The Netherlands.

Aim: The aims of this study were: (1) to determine the incidence and nature of adverse effects on oral motor function after first injections of botulinum neurotoxin A (BoNT-A) in submandibular glands for excessive drooling in children with central nervous system disorders; and (2) to identify independent predictors of these adverse effects.

Method: A cohort study involved 209 children (123 males, 86 females, aged 4-27y, median 8y 4mo), who received submandibular BoNT-A injections for drooling. Adverse effects were categorized into swallowing, eating, drinking, articulation, and other problems. Read More

Dev Med Child Neurol 2017 03 28;59(3):329-334. Epub 2016 Sep 28.

Service de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'informations sur le Médicament, CIC INSERM 1436, INSERM U 1027, Faculté de Médecine et Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

Aim: The aim of this study was to assess the risk of adverse drug reactions (ADRs) with botulinum neurotoxin type A (BoNT-A) in children with cerebral palsy (CP) using the World Health Organization global individual case safety report (ICSR) database, VigiBase.

Method: We extracted all children ICSRs for ADRs with BoNT-A used as anti-spastic drug in CP recorded between 1995 and 2015 in VigiBase. We also performed a case/non-case method (disproportionality analysis) to assess the link between exposure to BoNT-A and each ADR of interest in children and adults, calculating reporting odds ratios (RORs). Read More

J Neurol 2016 Apr 25;263(4):772-80. Epub 2016 Feb 25.

School of Medicine, Johns Hopkins University, 600 N. Wolfe Street, Meyer 6-181B, Baltimore, MD, 21287, USA.

A systematic pair-wise comparison of all available botulinum toxin serotype A and B treatments for cervical dystonia (CD) was conducted, as direct head-to-head clinical trial comparisons are lacking. Five botulinum toxin products: Dysport(®) (abobotulinumtoxinA), Botox(®) (onabotulinumtoxinA), Xeomin(®) (incobotulinumtoxinA), Prosigne(®) (Chinese botulinum toxin serotype A) and Myobloc(®) (rimabotulinumtoxinB) have demonstrated efficacy for managing CD. A pair-wise efficacy and safety comparison was performed for all toxins based on literature-reported clinical outcomes. Read More

Acta Neurol Scand 2016 Sep 25;134(3):224-31. Epub 2016 Jan 25.

Radboud University Medical Centre, Donders Centre for Neuroscience (DCN), Department of Rehabilitation/Speech-Language Pathology, Nijmegen, The Netherlands.

Objectives: Botulinum neurotoxin (BoNT) injections in the salivary glands and radiotherapy (RT) on these glands are commonly used to alleviate severe drooling in patients with amyotrophic lateral sclerosis (ALS). This study compares BoNT type A with RT based on patient-rated evaluations.

Materials & Methods: A prospective randomized controlled pilot study to compare RT (n = 10; on the parotid and the posterior part of the submandibular glands) with BoNT-A treatment (n = 10; in the parotid glands only, because of the risk of increasing oropharyngeal weakness) in patients with ALS. Read More

Can J Neurol Sci 2016 Mar 24;43(2):298-310. Epub 2015 Nov 24.

1Spasticity Research Program,West Park Healthcare Centre,University of Toronto,Toronto,Ontario,Canada.

Objective: The adverse events (AEs) with botulinum toxin type-A (BoNTA), used for indications other than spasticity, are widely reported in the literature. However, the site, dose, and frequency of injections are different for spasticity when compared to the treatment for other conditions and hence the AEs may be different as well. The objective of this study was to summarize the AEs reported in Canada and systematically review the AEs with intramuscular botulinum toxin injections to treat focal spasticity. Read More

J Neurol 2015 Dec 26;262(12):2662-7. Epub 2015 Sep 26.

Clinical and Biological Sciences Department, Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy.

Literature provides reports only of a limited follow-up single injection of botulinum toxin-A (BoNT-A) in patients with sialorrhea. The aim of our study is to evaluate the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for severe sialorrhea secondary to neurological dysphagia. We enrolled 38 severe adult sialorrhea patients referred consecutively to the neurology unit and performed bilateral parotid and submandibular gland BoNT-A injections under ultrasound guidance. Read More

Drug Des Devel Ther 2015 1;9:1913-26. Epub 2015 Apr 1.

Rush University Medical Center, Chicago, IL, USA.

Background: IncobotulinumtoxinA (Xeomin(®)) is a purified botulinum neurotoxin type A formulation, free from complexing proteins, with proven efficacy and good tolerability for the treatment of neurological conditions such as blepharospasm, cervical dystonia (CD), and post-stroke spasticity of the upper limb. This article provides a comprehensive overview of incobotulinumtoxinA based on randomized controlled trials and prospective clinical studies.

Summary: IncobotulinumtoxinA provides clinical efficacy in treating blepharospasm, CD, and upper-limb post-stroke spasticity based on randomized, double-blind, placebo-controlled trials with open-label extension periods (total study duration up to 89 weeks). Read More

J Neurol Sci 2014 Nov 10;346(1-2):116-20. Epub 2014 Aug 10.

Merz Pharmaceuticals GmbH, Eckenheimer Landstrasse 100, 60318 Frankfurt, Germany.

Typically, botulinum toxin injections for blepharospasm or cervical dystonia (CD) are administered at approximately 3-month intervals, reflecting concerns that shorter intervals might increase the risk of adverse events (AEs) and development of neutralizing antibodies. These post-hoc analyses investigated flexible incobotulinumtoxinA (Xeomin®) injection intervals (6-20 weeks) in patients with blepharospasm or CD. Patients received up to 6 injections at intervals ≥ 6 weeks, as determined by physician assessment upon patient request. Read More

J Neural Transm (Vienna) 2015 Feb 17;122(2):327-33. Epub 2014 Jul 17.

Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany,

Botulinum toxin (BT) used for dystonia and spasticity is dosed according to the number of target muscles and the severity of their muscle hyperactivities. With this no other drug is used in a broader dose range than BT. The upper end of this range, however, still needs to be explored. Read More

J Neural Transm (Vienna) 2013 Dec 19;120(12):1699-707. Epub 2013 Jun 19.

Movement Disorders Center of Arizona, 9590 E. Ironwood Square Drive, #225, Scottsdale, AZ, 85258, USA,

IncobotulinumtoxinA (Xeomin(®), NT 201), a preparation without accessory (complexing) proteins, has shown comparable efficacy and safety to onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the efficacy and safety of repeated incobotulinumtoxinA injections in subjects with CD. Following a ≤20-week placebo-controlled, randomized, double-blind, single-dose main period, subjects could enter a ≤68-week prospective, randomized, double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period with 240 U or 120 U of incobotulinumtoxinA (≤5 injections). Read More

J Neurol Neurosurg Psychiatry 2013 Sep 18;84(9):1014-9. Epub 2013 May 18.

Movement Disorders Section, Department of Neurology, Hannover Medical School, Hannover, Germany.

Introduction: Previously, controlled trials have demonstrated the efficacy and tolerability of fixed doses of incobotulinumtoxinA (Xeomin, NT 201, botulinum toxin type A free from complexing proteins) to treat cervical dystonia (CD). To explore the clinical relevance of these findings, this study evaluated long-term use of flexible dosing regimens of incobotulinumtoxinA in a setting close to real-life clinical practice.

Methods: Patients with CD received five injection sessions of incobotulinumtoxinA using flexible intervals (10-24 weeks) and dosing (≤300 Units) based on patients' needs. Read More

Tremor Other Hyperkinet Mov (N Y) 2013 18;3. Epub 2013 Apr 18.

Cleveland Clinic, Cleveland, Ohio, United States of America.

Background: To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD).

Methods: This was a prospective, double-blind, randomized, placebo-controlled, multicenter trial in botulinum toxin-treated or toxin-naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. Read More