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IncobotulinumtoxinA for hypersalivation in patients with amyotrophic lateral sclerosis: an open-label single-centre study

  • Neurology and Preclinical Neurological Studies - Original Article
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Abstract

The objective of this study is to discover whether incobotulinumtoxinA (inco) can reduce relative hypersalivation in patients with amyotrophic lateral sclerosis (ALS). 14 patients with ALS (8 males and 6 females, age 55.4 ± 16.3 years) received ultrasound-guided injection of inco 100 MU in both parotid glands and inco 50 MU in both submandibular glands. Saliva production was gravimetrically measured with three cotton rolls placed in the mouth. Weight increase after 5 min was measured on an electronic scale. Subjective saliva production was registered with drooling frequency scale (DFS) and drooling severity scale (DSS). Saliva production was gravimetrically reduced at week 4 (p = 0.04), week 8 (p = 0.01) but not after week 12 after BT application. DFS was reduced at week 4 (p = 0.04), week 8 (p = 0.02), but not after week 12. DSS was reduced at week 4 (p = 0.03), week 8 (p = 0.04) and week 12 (p = 0.04). Patients in our study did not experience changes in their swallowing patterns or any other safety-relevant events. Inco is effective and well tolerated for saliva reduction in patients with ALS for 8–12 weeks.

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References

  • Banfi P, Ticozzi N, Lax A, Guidugli GA, Nicolini A, Silani V (2015) A review of options for treating sialorrhea in amyotrophic lateral sclerosis. Respir Care 60:446–454

    Article  Google Scholar 

  • Benson J, Daugherty KK (2007) Botulinum toxin A in the treatment of sialorrhea. Ann Pharmacother 41:79–85

    Article  CAS  Google Scholar 

  • Brodsky MA, Swope DM, Grimes D (2012) Diffusion of botulinum toxins. Tremor Other Hyperkinet Mov. https://doi.org/10.7916/d88w3c1m

    Article  Google Scholar 

  • Contarino M, Pompili M, Tittoto P, Vanacore N, Sabatelli M, Cedrone A, Rapaccini G, Gasbarrini G, Tonali P, Bentivoglio A (2007) Botulinum toxin B ultrasound-guided injections for sialorrhea in amyotrophic lateral sclerosis and Parkinson’s disease. Parkinsonism Relat Disord 13:299–303

    Article  Google Scholar 

  • Costa J, Rocha M, Ferreira J, Evangelista T, Coelho M, de Carvalho M (2008) Botulinum toxin type-B improves sialorrhea and quality of life in bulbar onset amyotrophic lateral sclerosis. J Neurol 255:545–550

    Article  CAS  Google Scholar 

  • Crysdale WS, White A (1989) Submandibular duct relocation for drooling: a 10-year experience with 194 patients. Otolaryngol Head Neck Surg 101:87–92

    Article  CAS  Google Scholar 

  • Dressler D, Foster K (2018) Pharmacology of botulinum toxins. In: Dressler D, Altenmüller E, Krauss JK (eds) Treatment of dystonia. Cambridge University Press, Cambridge

    Chapter  Google Scholar 

  • Ellies M, Laskawi R, Tormählen G, Götz W (2000) The effect of local injection of botulinum toxin A on the parotid gland of the rat: an immunohistochemical and morphometric study. J Oral Maxillofac Surg 58:1251–1256

    Article  CAS  Google Scholar 

  • Erasmus CE, Van Hulst K, Van Den Hoogen FJ, Van Limbeek J, Roeleveld N, Veerman EC, Rotteveel JJ, Jongerius PH (2010) Thickened saliva after effective management of drooling with botulinum toxin A. Dev Med Child Neurol 52:114–118

    Article  Google Scholar 

  • Giess R, Werner E, Beck M, Reiners C, Toyka KV, Naumann M (2002) Impaired salivary gland function reveals autonomic dysfunction in amyotrophic lateral sclerosis. J Neurol 249:1246–1249

    Article  Google Scholar 

  • Gilio F, Iacovelli E, Frasca V, Gabriele M, Giacomelli E, Pic-chiori F, Soldo P, Cipriani AM, Ruoppolo G, Inghilleri M (2010) Botulinum toxin type A for the treatment of sialorrhoea in amyotrophic lateral sclerosis: a clinical and neurophysiological study. Amyotroph Later Scler 11:359–363

    Article  CAS  Google Scholar 

  • Guidubaldi A, Fasano A, Ialongo T, Piano C, Pompili M, Mascianà R, Siciliani L, Sabatelli M, Bentivoglio AR (2011) Botulinum toxin A versus B in sialorrhea: a prospective, randomized, double-blind, crossover pilot study in patients with amyotrophic lateral sclerosis or Parkinson’s disease. Mov Disord 26:313–319

    Article  Google Scholar 

  • Hockstein NG, Samadi DS, Gendron K, Handler SD (2004) Sialorrhea: a management challenge. Am Fam Phys 69:2628–2634

    Google Scholar 

  • Ichikawa K, Sakuma S, Yoshihara A, Miyazaki H, Funayama S, Ito K, Igarashi A (2010) Relationships between the amount of saliva and medications in elderly individuals. Gerodontology 28:116–120

    Article  Google Scholar 

  • Jackson CE, Gronseth G, Rosenfeld J, Barohn RJ, Dubinsky R, Simpson CB, McVey A, Kittrell PP, King R, Herbelin L, Muscle Study Group (2009) Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients. Muscle Nerve 39:137–143

    Article  CAS  Google Scholar 

  • Martínez-Poles J, Nedkova-Hristova V, Escribano-Paredes JB, García-Madrona S, Natera-Villalba E, Estévez-Fraga C, López-Sendón Moreno JL, Avilés-Olmos I, Sánchez Díaz G, Martínez Castrillo JC, Alonso-Canovas A (2018) IncobotulinumtoxinA for sialorrhea in neurological disorders: a real-life experience. Toxins. https://doi.org/10.3390/toxins10060217

    Article  PubMed  PubMed Central  Google Scholar 

  • McGeachan AJ, Mcdermott CJ (2017) Management of oral secretions in neurological diseases. Pract Neurol 17:96–103

    Article  Google Scholar 

  • Narayanaswami P, Geisbush T, Tarulli A, Raynor E, Gautam S, Tarsy D, Gronseth G (2016) Drooling in Parkinson’s disease: a randomized controlled trial of incobotulinumtoxinA and meta-analysis of botulinum toxins. Parkinsonism Relat Disord 30:73–77

    Article  Google Scholar 

  • Naumann M, Dressler D, Hallett M, Jankovic J, Schiavo G, Segal KR, Truong D (2013) Evidence-based review and assessment of botulinum neurotoxin for the treatment of secretory disorders. Toxicon 67:141–152

    Article  CAS  Google Scholar 

  • Neppelberg E, Haugen DF, Thorsen L, Tysnes OB (2007) Radiotherapy reduces sialorrhea in amyotrophic lateral sclerosis. Eur J Neurol 14:1373–1377

    Article  CAS  Google Scholar 

  • Restivo DA, Panebianco M, Casabona A, Lanza S, Marchese-Ragona R, Patti F, Masiero S, Biondi A, Quartarone A (2018) Botulinum toxin A for sialorrhoea associated with neurological disorders: evaluation of the relationship between effect of treatment and the number of glands treated. Toxins. https://doi.org/10.3390/toxins10020055

    Article  PubMed  PubMed Central  Google Scholar 

  • Rodriguez-Murphy E, Marti-Bonmati E, Camps-Segui E, Bagan JV (2011) Manually guided botulinum toxin type A submandibular injections for the treatment of sialorrhea in tube-fed patients with advanced amyotrophic lateral sclerosis. Am J Health Syst Pharm 68:1680–1681

    Article  Google Scholar 

  • Truong DD, Bhidayasiri R (2008) Evidence for the effectiveness of botulinum toxin for sialorrhoea. J Neural Transm 115:631–635

    Article  CAS  Google Scholar 

  • Verma A, Steele J (2006) Botulinum toxin improves sialorrhea and quality of living in bulbar amyotrophic lateral sclerosis. Muscle Nerve 34:235–237

    Article  CAS  Google Scholar 

Download references

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LP received honoraria for lectures from Merz. KK received travel grants and honoraria for lectures from Allergan, Biogen, Ipsen and Merz. MK received founding from the Hilde-Ulrich Foundation, Deutsche Parkinsonvereinigung and Arbeitskreis Botulinumtoxin. MK received honoraria for services to Abbvie. SP has received honoraria as speaker/consultant from Biogen Idec, Novartis, Cytokinetics, TEVA Pharmaceuticals, Desitin. DD received honoraria for consultations from Allergan, Ipsen, Merz, Medy-Tox, Lanzhou Institute of Biological Products, IAB-Interdisciplinary Working Group for Movement Disorders. He is a shareholder of Allergan. He holds patents in botulinum toxin research.

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Correspondence to Lejla Paracka.

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Paracka, L., Kollewe, K., Klietz, M. et al. IncobotulinumtoxinA for hypersalivation in patients with amyotrophic lateral sclerosis: an open-label single-centre study. J Neural Transm 126, 1341–1345 (2019). https://doi.org/10.1007/s00702-019-02044-6

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  • DOI: https://doi.org/10.1007/s00702-019-02044-6

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