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Trenkwalder, Claudia
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Trenkwalder, Claudia
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Trenkwalder, Claudia
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Trenkwalder, C.
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2014Journal Article [["dc.bibliographiccitation.artnumber","42"],["dc.bibliographiccitation.journal","BMC Neurology"],["dc.bibliographiccitation.volume","14"],["dc.contributor.author","Kassubek, Jan"],["dc.contributor.author","Chaudhuri, Kallol Ray"],["dc.contributor.author","Zesiewicz, Theresa"],["dc.contributor.author","Surmann, Erwin"],["dc.contributor.author","Boroojerdi, Babak"],["dc.contributor.author","Moran, Kimberly"],["dc.contributor.author","Ghys, Liesbet"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.date.accessioned","2018-11-07T09:42:40Z"],["dc.date.available","2018-11-07T09:42:40Z"],["dc.date.issued","2014"],["dc.description.abstract","Background: Pain is a troublesome non-motor symptom of Parkinson's disease (PD). The RECOVER (Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; Clintrials.gov: NCT00474058) study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain, and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance. Methods: PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Post hoc analyses for patients reporting 'any' pain (pain score = 1) at baseline, and subgroups reporting 'mild' (score 1-3), and 'moderate-to-severe' pain (score = 4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis (a responder defined as showing a = 30% reduction in early morning UPDRS III total score or PDSS-2 total score). As post hoc analyses, all p values presented are exploratory. Results: Of 267 patients with Likert pain data (178 rotigotine, 89 placebo), 187 (70%) reported 'any' pain; of these 87 (33%) reported 'mild', and 100 (37%) 'moderate-to-severe' pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with 'any' pain (-0.88 [95% CI: -1.56, -0.19], p = 0.013), and in the subgroup with 'moderate-to-severe' pain (-1.38 [-2.44, -0.31], p = 0.012). UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders. Conclusions: The results from this post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine; this may be partly attributable to benefits in motor function and sleep disturbances. Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings."],["dc.description.sponsorship","UCB Pharma, Brussels, Belgium"],["dc.identifier.doi","10.1186/1471-2377-14-42"],["dc.identifier.fs","611732"],["dc.identifier.isi","000332639900002"],["dc.identifier.pmid","24602411"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/11924"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/34008"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Biomed Central Ltd"],["dc.relation.issn","1471-2377"],["dc.rights.access","openAccess"],["dc.subject.mesh","Administration, Cutaneous"],["dc.subject.mesh","Adult"],["dc.subject.mesh","Aged"],["dc.subject.mesh","Aged, 80 and over"],["dc.subject.mesh","Dopamine Agonists"],["dc.subject.mesh","Female"],["dc.subject.mesh","Humans"],["dc.subject.mesh","Male"],["dc.subject.mesh","Middle Aged"],["dc.subject.mesh","Pain"],["dc.subject.mesh","Pain Measurement"],["dc.subject.mesh","Parkinson Disease"],["dc.subject.mesh","Prospective Studies"],["dc.subject.mesh","Tetrahydronaphthalenes"],["dc.subject.mesh","Thiophenes"],["dc.title","Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]Details DOI PMID PMC WOS2014Journal Article [["dc.bibliographiccitation.firstpage","140"],["dc.bibliographiccitation.issue","3-4"],["dc.bibliographiccitation.journal","European Neurology"],["dc.bibliographiccitation.lastpage","147"],["dc.bibliographiccitation.volume","71"],["dc.contributor.author","Swick, Todd J."],["dc.contributor.author","Friedman, Joseph H."],["dc.contributor.author","Chaudhuri, Kallol Ray"],["dc.contributor.author","Surmann, Erwin"],["dc.contributor.author","Boroojerdi, Babak"],["dc.contributor.author","Moran, Kimberly"],["dc.contributor.author","Ghys, Liesbet"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.date.accessioned","2018-11-07T09:46:20Z"],["dc.date.available","2018-11-07T09:46:20Z"],["dc.date.issued","2014"],["dc.description.abstract","Background: RECOVER (NCT00474058), a double-blind, placebo-controlled trial in patients with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control, demonstrated significant improvements with rotigotine in early-morning motor function (Unified Parkinson's Disease Rating Scale [UPDRS] III), and nocturnal sleep disturbances (modified Parkinson's Disease Sleep Scale [PDSS-2]), and improvements in nonmotor symptoms (NMS; Non-Motor Symptom Scale [NMSS]). Methods: Post hoc analyses investigated the correlation between motor symptom and NMS severity in PD by evaluating associations between UPDRS Ill and both NMSS and PDSS-2 scores. Categories were defined for UPDRS Ill, NMSS, and PDSS-2 total scores; analyses were conducted for the full analysis set (n = 267). Results: There was a trend toward increasing PDSS-2 and NMSS total and domain scores with increasing UPDRS Ill category at baseline and end of maintenance (EoM). Pearson correlation coefficients between UPDRS III and both NMSS and PDSS-2 total and domain scores were r=0.12-0.44 (r(2)=0.01-0.19) at baseline, r = 0.05-0.38 (r(2) = 0.00-0.14) at EoM, and r = -0.02-0.36 (r(2) = 0.00-0.13) for change from baseline to EoM. Conclusion: There was only a small correlation between severity of early-morning motor symptoms and overall burden of NMS and nocturnal sleep disturbances in RECOVER, suggesting that motor symptoms and NMS originate, at least partly, from distinct pathophysiological pathways. (C) 2014 S. Karger AG, Basel"],["dc.description.sponsorship","UCB Pharma, Smyrna, Ga., USA"],["dc.identifier.doi","10.1159/000355019"],["dc.identifier.isi","000333866400007"],["dc.identifier.pmid","24457253"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/34848"],["dc.language.iso","en"],["dc.notes.intern","DeepGreen Import"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","S. Karger AG"],["dc.relation.eissn","1421-9913"],["dc.relation.issn","1421-9913"],["dc.relation.issn","0014-3022"],["dc.rights","https://www.karger.com/Services/SiteLicenses"],["dc.title","Associations between Severity of Motor Function and Nonmotor Symptoms in Parkinson's Disease: A Post Hoc Analysis of the RECOVER Study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]Details DOI PMID PMC WOS2011Journal Article [["dc.bibliographiccitation.firstpage","90"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Movement Disorders"],["dc.bibliographiccitation.lastpage","99"],["dc.bibliographiccitation.volume","26"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.contributor.author","Kies, Bryan"],["dc.contributor.author","Rudzinska, Monika"],["dc.contributor.author","Fine, Jennifer"],["dc.contributor.author","Nikl, Janos"],["dc.contributor.author","Honczarenko, Krystyna"],["dc.contributor.author","Dioszeghy, Peter"],["dc.contributor.author","Hill, Dennis"],["dc.contributor.author","Anderson, Tim"],["dc.contributor.author","Myllyla, Vilho"],["dc.contributor.author","Kassubek, Jan"],["dc.contributor.author","Steiger, Malcolm"],["dc.contributor.author","Zucconi, Marco"],["dc.contributor.author","Tolosa, Eduardo"],["dc.contributor.author","Poewe, Werner"],["dc.contributor.author","Surmann, Erwin"],["dc.contributor.author","Whitesides, John"],["dc.contributor.author","Boroojerdi, Babak"],["dc.contributor.author","Chaudhuri, Kallol Ray"],["dc.date.accessioned","2018-11-07T09:01:44Z"],["dc.date.available","2018-11-07T09:01:44Z"],["dc.date.issued","2011"],["dc.description.abstract","In a multinational, double-blind, placebo-controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control were randomized 2: 1 to receive rotigotine (2-16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1-8 weeks with subsequent dose maintenance for 4 weeks. Early-morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS-2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by -7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by -3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS-2 total score had decreased by -5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by -1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: -3.55 [95% confidence interval (CI) -5.37, -1.73]; P = 0.0002) and PDSS-2 (treatment difference: -4.26 [95% CI -6.08, -2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances. (C) 2010 Movement Disorder Society"],["dc.description.sponsorship","Schwarz Biosciences GmbH"],["dc.identifier.doi","10.1002/mds.23441"],["dc.identifier.isi","000288178400018"],["dc.identifier.pmid","21322021"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/14053"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/24503"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Wiley-blackwell"],["dc.relation.issn","0885-3185"],["dc.rights","Goescholar"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.title","Rotigotine Effects on Early Morning Motor Function and Sleep in Parkinson's Disease: A Double-Blind, Randomized, Placebo-Controlled Study (RECOVER)"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]Details DOI PMID PMC WOS