{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T13:12:32Z","timestamp":1792156352493,"version":"4.4.0"},"reference-count":63,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2020,10,14]],"date-time":"2020-10-14T00:00:00Z","timestamp":1602633600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,3,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Study Objectives<\/jats:title><jats:p>Evaluate efficacy and safety of lower-sodium oxybate (LXB), a novel oxybate medication with 92% less sodium than sodium oxybate (SXB).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults aged 18\u201370 years with narcolepsy with cataplexy were eligible. The study included a \u226430-day screening period; a 12-week, open-label, optimized treatment and titration period to transition to LXB from previous medications for the treatment of cataplexy; a 2-week stable-dose period (SDP); a 2-week, double-blind, randomized withdrawal period (DBRWP); and a 2-week safety follow-up. During DBRWP, participants were randomized 1:1 to placebo or to continue LXB treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Efficacy was assessed in 134 participants who received randomized treatment, and safety was assessed in all enrolled participants (N = 201). Statistically significant worsening of symptoms was observed in participants randomized to placebo, with median (first quartile [Q1], third quartile [Q3]) change in weekly number of cataplexy attacks from SDP to DBRWP (primary efficacy endpoint) in the placebo group of 2.35 (0.00, 11.61) versus 0.00 (\u22120.49, 1.75) in the LXB group (p &amp;lt; 0.0001; mean [standard deviation, SD] change: 11.46 [24.751] vs 0.12 [5.772]), and median (Q1, Q3) change in Epworth Sleepiness Scale score (key secondary efficacy endpoint) of 2.0 (0.0, 5.0) in the placebo group versus 0.0 (\u22121.0, 1.0) in the LXB group (p &amp;lt; 0.0001; mean [SD] change: 3.0 [4.68] vs 0.0 [2.90]). The most common treatment-emergent adverse events with LXB were headache (20.4%), nausea (12.9%), and dizziness (10.4%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Efficacy of LXB for the treatment of cataplexy and excessive daytime sleepiness was demonstrated. The safety profile of LXB was consistent with SXB.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial registration<\/jats:title><jats:p>NCT03030599.<\/jats:p><\/jats:sec>","DOI":"10.1093\/sleep\/zsaa206","type":"journal-article","created":{"date-parts":[[2020,10,14]],"date-time":"2020-10-14T18:13:44Z","timestamp":1602699224000},"source":"Crossref","is-referenced-by-count":68,"title":["Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy"],"prefix":"10.1093","volume":"44","author":[{"given":"Richard K","family":"Bogan","sequence":"first","affiliation":[{"name":"School of Medicine, University of South Carolina, Columbia, SC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Thorpy","sequence":"additional","affiliation":[{"name":"Department of Neurology, Albert Einstein College of Medicine, Bronx, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Dauvilliers","sequence":"additional","affiliation":[{"name":"Sleep and Wake Disorders Centre, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France"},{"name":"Department of Neurology, University of Montpellier, INSERM U1061, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markku","family":"Partinen","sequence":"additional","affiliation":[{"name":"Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1652-4215","authenticated-orcid":false,"given":"Rafael","family":"Del Rio Villegas","sequence":"additional","affiliation":[{"name":"Neurophysiology and Sleep Disorders Unit, Hospital Vithas Nuestra Se\u00f1ora de America, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Foldvary-Schaefer","sequence":"additional","affiliation":[{"name":"Sleep Disorders Center, Cleveland Clinic, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Skowronski","sequence":"additional","affiliation":[{"name":"Global Clinical Development, Jazz Pharmaceuticals, Inc., Palo Alto, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lihua","family":"Tang","sequence":"additional","affiliation":[{"name":"Biostatistics, Jazz Pharmaceuticals, Inc., Palo Alto, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck","family":"Skobieranda","sequence":"additional","affiliation":[{"name":"Global Clinical Development, Jazz Pharmaceuticals, Inc., Palo Alto, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5773-9656","authenticated-orcid":false,"given":"Karel","family":"\u0160onka","sequence":"additional","affiliation":[{"name":"Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,10,14]]},"reference":[{"key":"2021072613100444700_CIT0001","first-page":"125","article-title":"Epidemiology of narcolepsy.","volume-title":"Narcolepsy and Hypersomnia. 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