{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T17:08:53Z","timestamp":1791220133026,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T00:00:00Z","timestamp":1667520000000},"content-version":"vor","delay-in-days":307,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Parkinson's Disease"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:p><jats:italic>Background<\/jats:italic>. Nonmotor symptoms (NMS) are common in advanced Parkinson\u2019s disease (APD) and reduce health\u2010related quality of life. <jats:italic>Objective<\/jats:italic>. The aim of the study was to evaluate levodopa\u2010carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) on NMS in APD. <jats:italic>Methods<\/jats:italic>. INSIGHTS was a phase 3b, open\u2010label, randomized, multicenter study in patients with APD (LCIG or OMT, 26 weeks) (NCT02549092). Primary outcomes assessed were total NMS (NMS scale (NMSS) and PD sleep scale (PDSS\u20102)). Key secondary outcomes included the Unified PD Rating Scale (UPDRS) Part II, Clinical Global Impression of Change (CGI\u2010C), and PD Questionnaire\u20108 (PDQ\u20108). Additional secondary measures of Patient Global Impression of Change (PGIC), King\u2019s PD Pain Scale (KPPS), and Parkinson Anxiety Scale (PAS) also were evaluated. Finally, safety was assessed. <jats:italic>Results<\/jats:italic>. Out of 89 patients randomized, 87 were included in the analysis (LCIG, <jats:italic>n<\/jats:italic>\u2009=\u200943; OMT, <jats:italic>n<\/jats:italic>\u2009=\u200944). There were no significant differences in NMSS or PDSS\u20102 total score changes (baseline to Week 26) between LCIG and OMT; within\u2010group changes were significant for NMSS (LCIG, <jats:italic>p<\/jats:italic> &lt; 0.001; OMT, <jats:italic>p<\/jats:italic> = 0.005) and PDSS\u20102 (LCIG, <jats:italic>p<\/jats:italic> &lt; 0.001; OMT, <jats:italic>p<\/jats:italic> &lt; 0.001). Between\u2010group treatment differences were nominally significant for UPDRS Part II (<jats:italic>p<\/jats:italic> = 0.006) and CGI\u2010C (<jats:italic>p<\/jats:italic> &lt; 0.001) at Week 26 in favor of LCIG; however, statistical significance could not be claimed in light of primary efficacy outcomes. PGIC (Week 26) and KPPS (Week 12) scores were nominally significantly reduced with LCIG versus OMT (<jats:italic>p<\/jats:italic> &lt; 0.001; <jats:italic>p<\/jats:italic> &lt; 0.05). There were no significant differences in PDQ\u20108 or PAS. Adverse events (AEs) were mostly mild to moderate; common serious AEs were pneumoperitoneum (<jats:italic>n<\/jats:italic>\u2009=\u20092) and stoma\u2010site infection (<jats:italic>n<\/jats:italic>\u2009=\u20092) (LCIG). <jats:italic>Conclusions<\/jats:italic>. There were no significant differences between LCIG versus OMT in NMSS or PDSS\u20102; both LCIG and OMT groups significantly improved from baseline. AEs were consistent with the known safety profile.<\/jats:p>","DOI":"10.1155\/2022\/1216975","type":"journal-article","created":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T23:20:09Z","timestamp":1667604009000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Effects of Levodopa\u2010Carbidopa Intestinal Gel Compared with Optimized Medical Treatment on Nonmotor Symptoms in Advanced Parkinson\u2019s Disease: INSIGHTS Study"],"prefix":"10.1155","volume":"2022","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4118-8233","authenticated-orcid":false,"given":"Sun Ju","family":"Chung","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6943-3707","authenticated-orcid":false,"given":"Matilde","family":"Calopa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2694-4638","authenticated-orcid":false,"given":"Maria G.","family":"Ceravolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1497-4482","authenticated-orcid":false,"given":"Nicola","family":"Tambasco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1040-2807","authenticated-orcid":false,"given":"Angelo","family":"Antonini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2815-0505","authenticated-orcid":false,"given":"K. 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