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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
Author(s) -
Antonini A.,
Bauer L.,
Dohin E.,
Oertel W. H.,
Rascol O.,
Reichmann H.,
Schmid M.,
Singh P.,
Tolosa E.,
Chaudhuri K. Ray
Publication year - 2015
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.12757
Subject(s) - rotigotine , medicine , placebo , parkinson's disease , nausea , randomized controlled trial , levodopa , adverse effect , transdermal patch , apathy , anesthesia , physical therapy , transdermal , disease , pharmacology , alternative medicine , pathology
Background and purpose Non‐motor symptoms ( NMS ) of Parkinson's disease ( PD ) have a major impact on health‐related quality of life. This is the first randomized controlled trial to use the NMS Scale ( NMSS ) as a primary outcome to assess treatment effects on NMS in PD . Methods In this double‐blind trial ( NCT 01300819), patients with PD and a total NMSS score ≥40 were randomized (2:1) to rotigotine or placebo, titrated over 1–7 weeks to optimal dose (≤8 mg/24 h for patients not receiving levodopa, ≤16 mg/24 h for patients receiving levodopa), maintained for 12 weeks. The primary outcome was change in NMSS total score from baseline to end of maintenance. Secondary outcomes were the nine NMSS domains, Unified Parkinson's Disease Rating Scale ( UPDRS ) III (motor) and the 39‐item Parkinson's Disease Questionnaire ( PDQ ‐39). Results In total, 283/349 (81.1%) randomized patients completed the trial; 211 rotigotine and 122 placebo were included in the full analysis set. The NMSS total score decreased by 23 (rotigotine) and 19 (placebo) points; the treatment difference was not statistically significant (−3.58; 95% confidence interval −8.43, 1.26; P = 0.147). Numerically greater than placebo improvements were detected in the ‘mood/apathy’ and ‘miscellaneous’ NMSS domains ( P < 0.05). Treatment differences in UPDRS III (−2.60; −4.27, −0.92; P = 0.002) and PDQ ‐39 (−2.79; −5.21, −0.37; P = 0.024) favoured rotigotine. Adverse events reported more frequently with rotigotine were nausea, application site reactions, somnolence and headache. Conclusions Rotigotine improvement in the multi‐domain NMSS total score was not superior to placebo. A different sensitivity of individual NMSS domains to dopaminergic therapy and a large placebo effect may have contributed to these findings.