Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non‐motor symptoms – results of a double‐blind, randomized, placebo‐controlled trial

• DOI: 10.1111/ene.12757
• Publication Date: 2015-06-22T05:29:15Z
• Authors: A. Antonini; L. Bauer; E. Dohin; W. H. Oertel; O. Rascol; H. Reichmann; M. Schmid; P. Singh; E. Tolosa; K. Ray Chaudhuri
• Keywords: Rotigotine; Transdermal patch; Motor symptoms

Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality life. This is the first randomized controlled trial to use NMS Scale (NMSS) as primary outcome assess treatment effects in PD.In this double-blind (NCT01300819), patients with PD and total NMSS score ≥40 were (2:1) rotigotine or placebo, titrated over 1-7 weeks optimal dose (≤8 mg/24 h for not receiving levodopa, ≤16 levodopa), maintained 12 weeks. The was change from baseline end maintenance. Secondary outcomes nine domains, Unified Disease Rating (UPDRS) III (motor) 39-item Questionnaire (PDQ-39).In total, 283/349 (81.1%) completed trial; 211 122 placebo included full analysis set. decreased by 23 (rotigotine) 19 (placebo) points; difference statistically significant (-3.58; 95% confidence interval -8.43, 1.26; P = 0.147). Numerically greater than improvements detected 'mood/apathy' 'miscellaneous' domains (P < 0.05). Treatment differences UPDRS (-2.60; -4.27, -0.92; 0.002) PDQ-39 (-2.79; -5.21, -0.37; 0.024) favoured rotigotine. Adverse events reported more frequently nausea, application site reactions, somnolence headache.Rotigotine improvement multi-domain superior placebo. A different sensitivity individual dopaminergic therapy large effect may contributed these findings.