{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T01:20:55Z","timestamp":1790299255798,"version":"4.1.0"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T00:00:00Z","timestamp":1713225600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Study Objectives<\/jats:title>\n                  <jats:p>Iron therapy is associated with improvements in restless legs syndrome (RLS). This multicenter, randomized, double-blind study evaluated the effect of intravenous ferric carboxymaltose (FCM) on RLS.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 209 adult patients with a baseline International RLS (IRLS) score\u2005\u2265\u200515 were randomized (1:1) to FCM (750 mg\/15 mL) or placebo on study days 0 and 5. Ongoing RLS medication was tapered starting on Day 5, with the goal of discontinuing treatment or achieving the lowest effective dose. Co-primary efficacy endpoints were changed from baseline in IRLS total score and the proportion of patients rated as much\/very much improved on the Clinical Global Impression (CGI)\u2013investigator (CGI-I) scale at day 42 in the \u201cAs-Treated\u201d population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The \u201cAs-Treated\u201d population comprised 107 FCM and 101 placebo recipients; 88 (82.2%) and 68 (67.3%), respectively, completed the day 42 assessment. The IRLS score reduction was significantly greater with FCM versus placebo: least-squares mean (95% confidence interval [CI]) \u22128.0 (\u22129.5, \u22126.4) versus \u22124.8 (\u22126.4, \u22123.1); p\u2005=\u2005.0036. No significant difference was observed in the proportion of FCM (35.5%) and placebo (28.7%) recipients with a CGI-I response (odds ratio 1.37 [95% CI: 0.76, 2.47]; p\u2005=\u2005.2987). Fewer patients treated with FCM (32.7%) than placebo (59.4%) received RLS interventions between day 5 and study end (p\u2005=\u2005.0002). FCM was well tolerated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The IRLS score improved with intravenous FCM versus placebo, although the combination of both co-primary endpoints was not met. Potential methodological problems in the study design are discussed.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/sleep\/zsae095","type":"journal-article","created":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T22:27:30Z","timestamp":1713306450000},"source":"Crossref","is-referenced-by-count":14,"title":["Clinical efficacy and safety of intravenous ferric carboxymaltose for treatment of restless legs syndrome: a multicenter, randomized, placebo-controlled clinical trial"],"prefix":"10.1093","volume":"47","author":[{"given":"Christopher J","family":"Earley","sequence":"first","affiliation":[{"name":"Department of Neurology, Johns Hopkins School of Medicine , Baltimore, MD , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1083-9654","authenticated-orcid":false,"given":"Diego","family":"Garc\u00eda-Borreguero","sequence":"additional","affiliation":[{"name":"Sleep Research Institute , Madrid , 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