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• W658451572 abstract "OBJECTIVE: To evaluate efficacy/safety of rotigotine transdermal system ≤8 mg/24h (maximum approved dose for advanced-PD in US: 8 mg/24h) and >8 mg/24h (maximum approved dose for advanced-PD elsewhere: 16 mg/24h) in patients with PD and unsatisfactory early-morning motor symptom control.BACKGROUND: The RECOVER study (NCT00474058) demonstrated significant improvements in early-morning motor function and sleep disturbances with rotigotine (2-16 mg/24h).DESIGN/METHODS: In RECOVER, patients were randomized to optimal dose (2-16 mg/24h) rotigotine or placebo: 1-8 weeks titration; 4-week maintenance. Co-primary outcomes were early-morning motor function (UPDRS III) and nocturnal sleep disturbance (PDSS-2). Post-hoc analyses for patients receiving rotigotine ≤8 mg/24h and >8 mg/24h (longest duration dose) were performed. As post-hoc analyses, p-values are exploratory.RESULTS: 96 patients received placebo, 84 rotigotine ≤8 mg/24h, and 107 rotigotine >8 mg/24h. Mean±SD UPDRS III score decreased by 6.6±7.5 with rotigotine ≤8 mg/24h (baseline 30.6±13.2), 7.3±7.6 rotigotine >8 mg/24h (baseline 29.1±11.9), and 3.9±7.3 placebo (baseline 31.8±13.6), representing greater improvement with both rotigotine groups vs placebo: rotigotine ≤8 mg/24h LS-mean (95[percnt] CI) placebo-treatment difference -3.09 (-5.23,-0.95), p=0.0050; rotigotine >8 mg/24h -3.95 (-6.02,-1.88), p=0.0002. PDSS-2 score decreased by 5.1±6.9 with rotigotine ≤8 mg/24h (baseline 17.9±8.1), 6.4±8.1 rotigotine >8 mg/24h (baseline 20.4±9.9), and 1.9±8.2 placebo (baseline 20.3±10.2), representing greater improvement with both rotigotine groups vs placebo: ≤8 mg/24h -3.84 (-6.10,-1.57), p=0.0010; >8 mg/24h -4.51 (-6.66,-2.37), p 8 mg/24h, 22[percnt]), application site reactions (4[percnt]; 14[percnt]; 16[percnt]), dizziness (6[percnt]; 10[percnt]; 11[percnt]).CONCLUSIONS: Both rotigotine dose groups showed clinically meaningful improvements vs placebo in patients with PD and unsatisfactory early-morning motor symptom control.Study Supported by: UCB Pharma Disclosure: Dr. Boroojerdi has received personal compensation for activities with UCB Pharma as an employee. Dr. Asgharnejad has received personal compensation for activities with UCB Pharma as an employee. Dr. Benitez Diaz has received personal compensation for activities with UCB Pharma as an employee. Dr. Surmann has received personal compensation for activities with UCB Pharma as an employee. Dr. Bauer has received personal compensation for activities with UCB Pharma as an employee." @default.
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• W658451572 date "2015-04-06" @default.
• W658451572 modified "2023-09-26" @default.
• W658451572 title "Rotigotine in Patients with PD and Unsatisfactory Early-morning Motor Symptom Control: a Post-hoc Analysis of Efficacy and Safety by Dose (P1.190)" @default.
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