{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:46:19Z","timestamp":1789785979313,"version":"4.0.1"},"reference-count":53,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,5,9]],"date-time":"2017-05-09T00:00:00Z","timestamp":1494288000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["U01NS080818"],"award-info":[{"award-number":["U01NS080818"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["U01NS080840"],"award-info":[{"award-number":["U01NS080840"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ann Clin Transl Neurol"],"published-print":{"date-parts":[[2017,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To describe the rationale for a novel study design and baseline characteristics of a disease\u2010modifying trial of isradipine 10 mg daily in early Parkinson disease (<jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">STEADY<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PDIII<\/jats:styled-content> is a 36\u2010month, Phase 3, parallel group, placebo\u2010controlled study of the efficacy of isradipine 10 mg daily in 336 participants with early <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content> as measured by the change in the Unified Parkinson Disease Rating Scale (<jats:styled-content style=\"fixed-case\">UPDRS<\/jats:styled-content>) Part I\u2010<jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> score in the practically defined <jats:styled-content style=\"fixed-case\">ON<\/jats:styled-content> state. <jats:italic>Secondary outcome<\/jats:italic> measures include clinically meaningful measures of disability progression in early <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>: (1) Time to initiation and utilization of dopaminergic therapy; (2) Time to onset of motor complications; (3) Change in nonmotor disability. Exploratory measures include global measures of functional disability, quality of life, change in the ambulatory capacity, cognitive function, and pharmacokinetic analysis. Rationale for the current design and alternative design approaches are discussed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The entire cohort of 336 participants was enrolled at 55 Parkinson Study Group sites in North America. The percentage of male participants were 68.5% with a mean age of 61.9 years (sd 9.0), mean Hoehn and Yahr stage of 1.7 (sd 0.5), mean <jats:styled-content style=\"fixed-case\">UPDRS<\/jats:styled-content> total of 23.1 (sd 8.6), and Mo<jats:styled-content style=\"fixed-case\">CA<\/jats:styled-content> of 28.1 (sd 1.4).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">STEADY<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PD III<\/jats:styled-content> has a novel and innovative design allowing for the determination of longer duration benefits on clinically relevant outcomes in a relatively small cohort on top of the benefit derived from symptomatic therapy. Baseline characteristics are similar to those in previously enrolled de novo <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content> trials. This study represents a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content> disability and provide clinically meaningful benefits.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acn3.412","type":"journal-article","created":{"date-parts":[[2017,5,9]],"date-time":"2017-05-09T07:42:46Z","timestamp":1494315766000},"page":"360-368","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":69,"title":["A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY\u2010PD III)"],"prefix":"10.1002","volume":"4","author":[{"given":"Kevin M.","family":"Biglan","sequence":"first","affiliation":[{"name":"Department of Neurology University of Rochester Rochester New York"},{"name":"Center for Human Experimental Therapeutics University of Rochester Rochester New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Oakes","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Computational Biology University of Rochester Rochester New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony E.","family":"Lang","sequence":"additional","affiliation":[{"name":"Morton and Gloria Shulman Movement Disorder Unit &amp; Edmond J. 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