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Clinical signs and symptoms and patient-reported outcomes from the SONICS trial were evaluated in the current manuscript.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients titrated to an individualized therapeutic dose entered a 6-month maintenance phase. Secondary endpoints included investigator-graded clinical signs and symptoms of CS during the maintenance phase, and patient-reported quality of life (CushingQoL questionnaire) and depression symptoms (Beck Depression Inventory II [BDI-II]).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of 94 enrolled patients, 77 entered the maintenance phase following individualized dose titration. Significant mean improvements from baseline were noted at end of maintenance (Month 6) for acne, hirsutism (females only), and peripheral edema. These improvements were observed as early as Day 1 of maintenance for hirsutism (mean baseline score, 7.8; \u2206 \u2212\u00a01.9; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001), end of Month 1 for acne (mean baseline score, 2.8; \u2206 \u2212\u00a01.2; <jats:italic>P<\/jats:italic>\u2009=\u20090.0481), and Month 4 for peripheral edema (mean baseline score, 1.0; \u2206 \u2212\u00a00.5; <jats:italic>P<\/jats:italic>\u2009=\u20090.0052). Significant mean improvements from baseline were observed by Month 3 of maintenance for CushingQoL (mean baseline score, 44.3; \u2206 +\u00a06.9; <jats:italic>P<\/jats:italic>\u2009=\u20090.0018) and at Month 6 for BDI-II (mean baseline score, 17.1; \u2206 \u2212\u00a04.3; <jats:italic>P<\/jats:italic>\u2009=\u20090.0043) scores. No significant mean improvement was identified in a composite score of 7 other clinical signs and symptoms.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Treatment with levoketoconazole was associated with sustained, meaningful improvements in QoL, depression, and certain clinical signs and symptoms characteristic of CS.<\/jats:p>\n                <jats:p><jats:bold>ClinialTrials.gov identifier<\/jats:bold>: NCT01838551.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s11102-020-01103-6","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T05:34:59Z","timestamp":1605850499000},"page":"104-115","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing\u2019s syndrome"],"prefix":"10.1007","volume":"24","clinical-trial-number":[{"clinical-trial-number":"nct01838551","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3722-1889","authenticated-orcid":false,"given":"Eliza B.","family":"Geer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Salvatori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atanaska","family":"Elenkova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Fleseriu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosario","family":"Pivonello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Przemyslaw","family":"Witek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard A.","family":"Feelders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Bex","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stina W.","family":"Borresen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soraya","family":"Puglisi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beverly M. 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RS reports serving as the principal investigator of research grants to Johns Hopkins University from Novartis, Corcept, Crinetics, and Strongbridge Biopharma; and receiving consulting honoraria from Novo Nordisk. AE reports serving as the principal investigator\/sub-investigator of clinical trials for Corcept Therapeutics and Novartis and receiving consulting honoraria from Novartis. MF reports serving as an investigator with research grants to OHSU for Millendo, Novartis, and Strongbridge Biopharma; and serving as an occasional consultant to Novartis and Strongbridge Biopharma. RP reports serving as the principal investigator of research grants to Federico II University from Corcept Therapeutics, Novartis, and Strongbridge Biopharma; and receiving consulting honoraria from Novartis and Strongbridge Biopharma. PW reports receiving travel grants from Ipsen and Novartis; and receiving personal fees as a clinical investigator from Ipsen, Novartis, Novo Nordisk, and Strongbridge Biopharma. RAF reports receiving research grants from Novartis; and serving on the speakers\u2019 bureau for HRA Pharma and Novartis. MB reports receiving research grants from Strongbridge Biopharma. SWB reports no conflicts of interest. SP reports receiving research grants from HRA Pharma. BMKB reports serving as the principal investigator of research grants to Massachusetts General Hospital from Millendo, Novartis, and Strongbridge Biopharma; and serving as an occasional consultant to Novartis and Strongbridge Biopharma. FC reports being an employee of Strongbridge Biopharma. FPG reports receiving consulting honoraria from Novartis, HRA Pharma, and IBI-Lorenzini.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was approved by an institutional review board or independent ethics committee at each site and conducted in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice and the ethical principles of the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was provided by each patient to participate in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}