Pharmacokinetics of rotigotine transdermal system in adolescents with idiopathic restless legs syndrome (Willis–Ekbom disease)
作者: Jan-Peer ElshoffJohn HudsonDaniel L. PicchiettiKeith RidelArthur S. WaltersKim DoggettKimberly MoranMarga OortgiesenFrancisco RamirezErwin Schollmayer
作者单位: 1UCB Pharma, Monheim am Rhein, Germany
2FutureSearch Trials of Neurology and Sleep Lab, Austin, TX, USA
3University of Illinois School of Medicine at Urbana-Champaign and Carle Foundation Hospital, Urbana, IL, USA
4Josephson Wallack Munshower Neurology, Indianapolis, IN, USA
5Department of Neurology, Vanderbilt University School of Medicine, Nashville, TN, USA
6UCB Pharma, Raleigh, NC, USA
7UCB Pharma, Smyrna, GA, USA
刊名: Sleep Medicine, 2016
来源数据库: Elsevier Journal
DOI: 10.1016/j.sleep.2016.04.012
关键词: Restless legs syndromeWillis–Ekbom diseaseSleep disorderAdolescentPeriodic limb movements in sleepDopamine agonist
英文摘要: Abstract(#br)Objective(#br)To investigate the pharmacokinetics (PK) of rotigotine transdermal system in adolescents with moderate-to-severe idiopathic restless legs syndrome (RLS).(#br)Methods(#br)This multicenter, open-label, dose-escalation study enrolled patients ≥13 to <18 years of age. Rotigotine transdermal patches were applied daily and up-titrated weekly: 0.5, 1, 2, 3 mg/24 h. Blood samples were collected on the final day of each dose step. Primary PK variables were the apparent total body clearance (CL/f; L/h) and volume of distribution at steady state (V SS /f; L) of unconjugated rotigotine for each dose step, calculated for the PK per-protocol set (PKPPS). Other PK, safety, and efficacy variables (International RLS Study Group Rating Scale [IRLS]; Clinical Global Impressions...
全文获取路径: Elsevier  (合作)
影响因子:3.487 (2012)