{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T07:11:19Z","timestamp":1767337879833,"version":"3.44.0"},"reference-count":24,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T00:00:00Z","timestamp":1738281600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Develop Med Child Neuro"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>To test the long\u2010term efficacy, safety, and impact on quality of life (QoL) of an oral paediatric formulation of 320\u2009\u03bcg\/mL glycopyrronium in the 36\u2010week SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>In the initial 12\u2010week blinded period, 87 children with neurodisabilities and severe sialorrhoea were randomized to 320\u2009\u03bcg\/mL glycopyrronium versus placebo. In the subsequent 24\u2010week open\u2010label study extension, 74 children received 320\u2009\u03bcg\/mL glycopyrronium (37 continued glycopyrronium, 37 switched from placebo).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The open\u2010label study extension population included 39 males and 35 females. The median age was 10\u2009years 2\u2009months (quartile 1, quartile 3: 7\u2009years 5\u2009months, 14\u2009years 7\u2009months; range: 3\u2009years 5\u2009months\u201317\u2009years 8\u2009months). Over 36\u2009weeks, continued 320\u2009\u03bcg\/mL glycopyrronium resulted in a median 39\u2010point reduction in Drooling Impact Scale (DIS) score from baseline (quartile 1, quartile 3: \u221251, \u221221; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), with an 81.1% response rate (DIS improvement\u2009\u2265\u200913.6 points) and a 70.3% good response rate (\u2265\u200928 points). Improvements in the impact of drooling on QoL seen in the blinded period were sustained with continued glycopyrronium. Treatment\u2010related adverse events occurred most frequently during titration (0\u20134\u2009weeks: 40.9%; 5\u201320\u2009weeks: 32.4% in those who switched). Constipation was the most common adverse event.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>Long\u2010term treatment with 320\u2009\u03bcg\/mL glycopyrronium resulted in significant sustained improvements in drooling and QoL, with fewer adverse events after initial titration and overall good tolerability.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dmcn.16251","type":"journal-article","created":{"date-parts":[[2025,1,31]],"date-time":"2025-01-31T13:33:41Z","timestamp":1738330421000},"page":"1085-1094","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Glycopyrronium 320\u2009\u03bcg\/<scp>mL<\/scp> in children and adolescents with severe sialorrhoea and neurodisabilities: An open\u2010label study extension of the <scp>SALIVA<\/scp> trial"],"prefix":"10.1111","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0740-4580","authenticated-orcid":false,"given":"Pierre","family":"Fayoux","sequence":"first","affiliation":[{"name":"Department of Paediatric Otolaryngology Head Neck Surgery Jeanne de Flandre Hospital  Lille France"},{"name":"Universit\u00e9 de Lille, ULR 2694\u2013METRICS: \u00c9valuation des Technologies de Sant\u00e9 et des Pratiques M\u00e9dicales  Lille France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6980-1178","authenticated-orcid":false,"given":"Mickael","family":"Dinomais","sequence":"additional","affiliation":[{"name":"Department of Physical Medicine and Rehabilitation CHU Angers\u2010Les Capucins  Angers France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7660-3930","authenticated-orcid":false,"given":"Helen","family":"Shaw","sequence":"additional","affiliation":[{"name":"Proveca Ltd  Manchester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6492-8153","authenticated-orcid":false,"given":"Fr\u00e9d\u00e9ric","family":"Villain","sequence":"additional","affiliation":[{"name":"Proveca Ltd  Manchester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-8784-9967","authenticated-orcid":false,"given":"D\u00e9borah","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Kappa Sant\u00e9  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincent","family":"Gautheron","sequence":"additional","affiliation":[{"name":"Department of Pediatric Physical Medicine and Rehabilitation, CHU Saint\u2010Etienne and UJM Saint\u2010Etienne, Interuniversity Laboratory of Motricity Biology University of Lyon\/Saint\u2010Etienne  Saint\u2010Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4495-0580","authenticated-orcid":false,"given":"Guy","family":"Letellier","sequence":"additional","affiliation":[{"name":"Department of Physical Medicine and Rehabilitation ESEAN\u2010APF  Nantes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3874-9749","authenticated-orcid":false,"given":"St\u00e9phane","family":"Auvin","sequence":"additional","affiliation":[{"name":"APHP, Service de Neurologie P\u00e9diatrique EpiCARE ERN Membre, H\u00f4pital Robert Debr\u00e9  Paris France"},{"name":"Universit\u00e9 Paris\u2010Cit\u00e9, INSERM NeuroDiderot  Paris France"},{"name":"Institut Universitaire de France  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,31]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-8749.2012.04382.x"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/dmcn.14316"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13052-022-01312-8"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0012162206000235"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00431-005-1759-z"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S39253"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2007.129478"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2023.1275807"},{"key":"e_1_2_12_10_1","unstructured":"US Food and Drug Administration.CUVPOSA label. 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