Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)
Identifieur interne : 000639 ( Main/Corpus ); précédent : 000638; suivant : 000640Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)
Auteurs : Claudia Trenkwalder ; Bryan Kies ; Monika Rudzinska ; Jennifer Fine ; Janos Nikl ; Krystyna Honczarenko ; Peter Dioszeghy ; Dennis Hill ; Tim Anderson ; Vilho Myllyla ; Jan Kassubek ; Malcolm Steiger ; Marco Zucconi ; Eduardo Tolosa ; Werner Poewe ; Erwin Surmann ; John Whitesides ; Babak Boroojerdi ; Kallol Ray Chaudhuri ; the RECOVER Study GroupSource :
- Movement Disorders [ 0885-3185 ] ; 2011-01.
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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. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.23441
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sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation><mods:affiliation>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><mods:affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation><mods:affiliation>UCB Pharma GmbH, Monheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Whitesides, John" sort="Whitesides, John" uniqKey="Whitesides J" first="John" last="Whitesides">John Whitesides</name><affiliation><mods:affiliation>Schwarz Biosciences Inc, a member of the UCB Group, Raleigh, NC, USA</mods:affiliation></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation><mods:affiliation>UCB Pharma GmbH, Monheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Chaudhuri, Kallol Ray" sort="Chaudhuri, Kallol Ray" uniqKey="Chaudhuri K" first="Kallol Ray" last="Chaudhuri">Kallol Ray Chaudhuri</name><affiliation><mods:affiliation>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="The Recover Study Group" sort="The Recover Study Group" uniqKey="The Recover Study Group" last="The Recover Study Group">the RECOVER Study Group</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:5E16E1D432ED9110E7448651B48C08D89C1CCA1B</idno><date when="2011" year="2011">2011</date><idno type="doi">10.1002/mds.23441</idno><idno type="url">https://api.istex.fr/document/5E16E1D432ED9110E7448651B48C08D89C1CCA1B/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">000639</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)</title><author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><affiliation><mods:affiliation>Department of Clinical Neurophysiology, University of Goettingen and Paracelsus‐Elena Klinik, Kassel, Germany</mods:affiliation></affiliation></author><author><name sortKey="Kies, Bryan" sort="Kies, Bryan" uniqKey="Kies B" first="Bryan" last="Kies">Bryan Kies</name><affiliation><mods:affiliation>Neurology Division, University of Cape Town, South Africa</mods:affiliation></affiliation></author><author><name sortKey="Rudzinska, Monika" sort="Rudzinska, Monika" uniqKey="Rudzinska M" first="Monika" last="Rudzinska">Monika Rudzinska</name><affiliation><mods:affiliation>Department of Neurology, Jagiellonian University Medical College, Krakow, Poland</mods:affiliation></affiliation></author><author><name sortKey="Fine, Jennifer" sort="Fine, Jennifer" uniqKey="Fine J" first="Jennifer" last="Fine">Jennifer Fine</name><affiliation><mods:affiliation>Constantiaberg MediClinic, Cape Town, South Africa</mods:affiliation></affiliation></author><author><name sortKey="Nikl, Janos" sort="Nikl, Janos" uniqKey="Nikl J" first="Janos" last="Nikl">Janos Nikl</name><affiliation><mods:affiliation>Department of Neurology, Hospital of Zala County, Zalaegerszeg, Hungary</mods:affiliation></affiliation></author><author><name sortKey="Honczarenko, Krystyna" sort="Honczarenko, Krystyna" uniqKey="Honczarenko K" first="Krystyna" last="Honczarenko">Krystyna Honczarenko</name><affiliation><mods:affiliation>Clinic of Neurology, Pomeranian Medical University, Szczecin, Poland</mods:affiliation></affiliation></author><author><name sortKey="Dioszeghy, Peter" sort="Dioszeghy, Peter" uniqKey="Dioszeghy P" first="Peter" last="Dioszeghy">Peter Dioszeghy</name><affiliation><mods:affiliation>Department of Neurology, County Hospital, Nyiregyhaza, Hungary</mods:affiliation></affiliation></author><author><name sortKey="Hill, Dennis" sort="Hill, Dennis" uniqKey="Hill D" first="Dennis" last="Hill">Dennis Hill</name><affiliation><mods:affiliation>Central Carolina Neurology and Sleep, Salisbury, North Carolina, USA</mods:affiliation></affiliation></author><author><name sortKey="Anderson, Tim" sort="Anderson, Tim" uniqKey="Anderson T" first="Tim" last="Anderson">Tim Anderson</name><affiliation><mods:affiliation>Department of Medicine, University of Otago, Christchurch, and Van Der Veer Institute, Christchurch, New Zealand</mods:affiliation></affiliation></author><author><name sortKey="Myllyla, Vilho" sort="Myllyla, Vilho" uniqKey="Myllyla V" first="Vilho" last="Myllyla">Vilho Myllyla</name><affiliation><mods:affiliation>Department of Neurology, Oulu University Hospital, Oulu, Finland</mods:affiliation></affiliation></author><author><name sortKey="Kassubek, Jan" sort="Kassubek, Jan" uniqKey="Kassubek J" first="Jan" last="Kassubek">Jan Kassubek</name><affiliation><mods:affiliation>Neurologische Klinik, Universität Ulm, Ulm, Germany</mods:affiliation></affiliation></author><author><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name><affiliation><mods:affiliation>The Walton Centre of Neurology and Neurosurgery, Liverpool, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name><affiliation><mods:affiliation>Centro per i Disturbi del Sonno, Instituto Scientifico H San Raffaele, Milan, Italy</mods:affiliation></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation><mods:affiliation>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><mods:affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation><mods:affiliation>UCB Pharma GmbH, Monheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Whitesides, John" sort="Whitesides, John" uniqKey="Whitesides J" first="John" last="Whitesides">John Whitesides</name><affiliation><mods:affiliation>Schwarz Biosciences Inc, a member of the UCB Group, Raleigh, NC, USA</mods:affiliation></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation><mods:affiliation>UCB Pharma GmbH, Monheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Chaudhuri, Kallol Ray" sort="Chaudhuri, Kallol Ray" uniqKey="Chaudhuri K" first="Kallol Ray" last="Chaudhuri">Kallol Ray Chaudhuri</name><affiliation><mods:affiliation>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="The Recover Study Group" sort="The Recover Study Group" uniqKey="The Recover Study Group" last="The Recover Study Group">the RECOVER Study Group</name></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2011-01">2011-01</date><biblScope unit="volume">26</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="90">90</biblScope><biblScope unit="page" to="99">99</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">5E16E1D432ED9110E7448651B48C08D89C1CCA1B</idno><idno type="DOI">10.1002/mds.23441</idno><idno type="ArticleID">MDS23441</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>dopamine agonist</term><term>motor function</term><term>quality of life</term><term>rotigotine</term><term>sleep</term><term>transdermal</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Claudia Trenkwalder MD</name><affiliations><json:string>Department of Clinical Neurophysiology, University of Goettingen and Paracelsus‐Elena Klinik, Kassel, Germany</json:string></affiliations></json:item><json:item><name>Bryan Kies FCNeurol (SA)</name><affiliations><json:string>Neurology Division, University of Cape Town, South Africa</json:string></affiliations></json:item><json:item><name>Monika Rudzinska MD</name><affiliations><json:string>Department of Neurology, Jagiellonian University Medical College, Krakow, Poland</json:string></affiliations></json:item><json:item><name>Jennifer Fine FCP (SA) Neurology</name><affiliations><json:string>Constantiaberg MediClinic, Cape Town, South Africa</json:string></affiliations></json:item><json:item><name>Janos Nikl MD</name><affiliations><json:string>Department of Neurology, Hospital of Zala County, Zalaegerszeg, Hungary</json:string></affiliations></json:item><json:item><name>Krystyna Honczarenko MD</name><affiliations><json:string>Clinic of Neurology, Pomeranian Medical University, Szczecin, Poland</json:string></affiliations></json:item><json:item><name>Peter Dioszeghy MD</name><affiliations><json:string>Department of Neurology, County Hospital, Nyiregyhaza, Hungary</json:string></affiliations></json:item><json:item><name>Dennis Hill MD</name><affiliations><json:string>Central Carolina Neurology and Sleep, Salisbury, North Carolina, USA</json:string></affiliations></json:item><json:item><name>Tim Anderson FRACP</name><affiliations><json:string>Department of Medicine, University of Otago, Christchurch, and Van Der Veer Institute, Christchurch, New Zealand</json:string></affiliations></json:item><json:item><name>Vilho Myllyla MD</name><affiliations><json:string>Department of Neurology, Oulu University Hospital, Oulu, Finland</json:string></affiliations></json:item><json:item><name>Jan Kassubek MD</name><affiliations><json:string>Neurologische Klinik, Universität Ulm, Ulm, Germany</json:string></affiliations></json:item><json:item><name>Malcolm Steiger FRCP</name><affiliations><json:string>The Walton Centre of Neurology and Neurosurgery, Liverpool, United Kingdom</json:string></affiliations></json:item><json:item><name>Marco Zucconi MD</name><affiliations><json:string>Centro per i Disturbi del Sonno, Instituto Scientifico H San Raffaele, Milan, Italy</json:string></affiliations></json:item><json:item><name>Eduardo Tolosa MD</name><affiliations><json:string>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Spain</json:string></affiliations></json:item><json:item><name>Werner Poewe MD</name><affiliations><json:string>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</json:string></affiliations></json:item><json:item><name>Erwin Surmann MSc</name><affiliations><json:string>UCB Pharma GmbH, Monheim, Germany</json:string></affiliations></json:item><json:item><name>John Whitesides PhD</name><affiliations><json:string>Schwarz Biosciences Inc, a member of the UCB Group, Raleigh, NC, USA</json:string></affiliations></json:item><json:item><name>Babak Boroojerdi MD</name><affiliations><json:string>UCB Pharma GmbH, Monheim, Germany</json:string></affiliations></json:item><json:item><name>Kallol Ray Chaudhuri DSc</name><affiliations><json:string>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, London, United Kingdom</json:string></affiliations></json:item><json:item><name>the RECOVER Study Group the RECOVER Study Group</name></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>dopamine agonist</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>rotigotine</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>transdermal</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>motor function</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>sleep</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>quality of life</value></json:item></subject><articleId><json:string>MDS23441</json:string></articleId><language><json:string>eng</json:string></language><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. © 2010 Movement Disorder Society</abstract><qualityIndicators><score>8</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>6</keywordCount><abstractCharCount>1826</abstractCharCount><pdfWordCount>5234</pdfWordCount><pdfCharCount>33963</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>264</abstractWordCount></qualityIndicators><title>Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study 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study (RECOVER)</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2011</date></publicationStmt><notesStmt><note type="content">*Potential conflict of interest: All investigators received grant payments from Schwarz Biosciences GmbH, a member of the UCB group of companies, for enrolling patients into the study.</note><note type="content">*Members of the “RECOVER Study Group” are listed as an Appendix.</note><note>Schwarz Biosciences GmbH</note><note>UCB Group of Companies</note><note>Schwarz Pharma Ltd, Ireland</note><note>Global Publications Manager</note><note>UCB Pharma SA</note><note>Evidence Scientific Solutions, Horsham, UK</note><note>Isis Innovation Limited</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)</title><author><persName><forename type="first">Claudia</forename><surname>Trenkwalder</surname></persName><roleName type="degree">MD</roleName><note type="correspondence"><p>Correspondence: Department of Clinical Neurophysiology, University of Goettingen, and Paracelsus Elena‐Klinik, Center of Parkinsonism and Movement Disorders, Kassel, Klinikstrasse 16, Kassel, Germany</p></note><affiliation>Department of Clinical Neurophysiology, University of Goettingen and Paracelsus‐Elena Klinik, Kassel, Germany</affiliation></author><author><persName><forename type="first">Bryan</forename><surname>Kies</surname></persName><roleName type="degree">FCNeurol (SA)</roleName><affiliation>Neurology Division, University of Cape Town, South Africa</affiliation></author><author><persName><forename type="first">Monika</forename><surname>Rudzinska</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Jagiellonian University Medical College, Krakow, Poland</affiliation></author><author><persName><forename type="first">Jennifer</forename><surname>Fine</surname></persName><roleName type="degree">FCP (SA) Neurology</roleName><affiliation>Constantiaberg MediClinic, Cape Town, South Africa</affiliation></author><author><persName><forename type="first">Janos</forename><surname>Nikl</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Hospital of Zala County, Zalaegerszeg, Hungary</affiliation></author><author><persName><forename type="first">Krystyna</forename><surname>Honczarenko</surname></persName><roleName type="degree">MD</roleName><affiliation>Clinic of Neurology, Pomeranian Medical University, Szczecin, Poland</affiliation></author><author><persName><forename type="first">Peter</forename><surname>Dioszeghy</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, County Hospital, Nyiregyhaza, Hungary</affiliation></author><author><persName><forename type="first">Dennis</forename><surname>Hill</surname></persName><roleName type="degree">MD</roleName><affiliation>Central Carolina Neurology and Sleep, Salisbury, North Carolina, USA</affiliation></author><author><persName><forename type="first">Tim</forename><surname>Anderson</surname></persName><roleName type="degree">FRACP</roleName><affiliation>Department of Medicine, University of Otago, Christchurch, and Van Der Veer Institute, Christchurch, New Zealand</affiliation></author><author><persName><forename type="first">Vilho</forename><surname>Myllyla</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Oulu University Hospital, Oulu, Finland</affiliation></author><author><persName><forename type="first">Jan</forename><surname>Kassubek</surname></persName><roleName type="degree">MD</roleName><affiliation>Neurologische Klinik, Universität Ulm, Ulm, Germany</affiliation></author><author><persName><forename type="first">Malcolm</forename><surname>Steiger</surname></persName><roleName type="degree">FRCP</roleName><affiliation>The Walton Centre of Neurology and Neurosurgery, Liverpool, United Kingdom</affiliation></author><author><persName><forename type="first">Marco</forename><surname>Zucconi</surname></persName><roleName type="degree">MD</roleName><affiliation>Centro per i Disturbi del Sonno, Instituto Scientifico H San Raffaele, Milan, Italy</affiliation></author><author><persName><forename type="first">Eduardo</forename><surname>Tolosa</surname></persName><roleName type="degree">MD</roleName><affiliation>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Spain</affiliation></author><author><persName><forename type="first">Werner</forename><surname>Poewe</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</affiliation></author><author><persName><forename type="first">Erwin</forename><surname>Surmann</surname></persName><roleName type="degree">MSc</roleName><affiliation>UCB Pharma GmbH, Monheim, Germany</affiliation></author><author><persName><forename type="first">John</forename><surname>Whitesides</surname></persName><roleName type="degree">PhD</roleName><affiliation>Schwarz Biosciences Inc, a member of the UCB Group, Raleigh, NC, USA</affiliation></author><author><persName><forename type="first">Babak</forename><surname>Boroojerdi</surname></persName><roleName type="degree">MD</roleName><affiliation>UCB Pharma GmbH, Monheim, Germany</affiliation></author><author><persName><forename type="first">Kallol Ray</forename><surname>Chaudhuri</surname></persName><roleName type="degree">DSc</roleName><affiliation>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, London, United Kingdom</affiliation></author><author><persName><surname>the RECOVER Study Group</surname></persName></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2011-01"></date><biblScope unit="volume">26</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="90">90</biblScope><biblScope unit="page" to="99">99</biblScope></imprint></monogr><idno type="istex">5E16E1D432ED9110E7448651B48C08D89C1CCA1B</idno><idno type="DOI">10.1002/mds.23441</idno><idno type="ArticleID">MDS23441</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2011</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>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. © 2010 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>dopamine agonist</term></item><item><term>rotigotine</term></item><item><term>transdermal</term></item><item><term>motor function</term></item><item><term>sleep</term></item><item><term>quality of life</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2010-06-22">Received</change><change when="2010-08-27">Registration</change><change when="2011-01">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/5E16E1D432ED9110E7448651B48C08D89C1CCA1B/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="10"><doi origin="wiley" registered="yes">10.1002/mds.v26.1</doi><numberingGroup><numbering type="journalVolume" number="26">26</numbering><numbering type="journalIssue">1</numbering></numberingGroup><coverDate startDate="2011-01">January 2011</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="180" status="forIssue" accessType="open"><doi origin="wiley" registered="yes">10.1002/mds.23441</doi><idGroup><id type="unit" value="MDS23441"></id></idGroup><countGroup><count type="pageTotal" number="10"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2010 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2010-06-22"></event><event type="manuscriptRevised" date="2010-08-06"></event><event 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elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS23441.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="3"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="30"></count><count type="wordTotal" number="7061"></count></countGroup><titleGroup><title type="main" xml:lang="en">Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)<link href="#fn9"></link><link href="#fn11"></link></title><title type="short" xml:lang="en">Rotigotine Recover Study</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Claudia</givenNames><familyName>Trenkwalder</familyName><degrees>MD</degrees></personName><contactDetails><email>ctrenkwalder@gmx.de</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Bryan</givenNames><familyName>Kies</familyName><degrees>FCNeurol (SA)</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Monika</givenNames><familyName>Rudzinska</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Jennifer</givenNames><familyName>Fine</familyName><degrees>FCP (SA) Neurology</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Janos</givenNames><familyName>Nikl</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Krystyna</givenNames><familyName>Honczarenko</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Peter</givenNames><familyName>Dioszeghy</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Dennis</givenNames><familyName>Hill</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af9"><personName><givenNames>Tim</givenNames><familyName>Anderson</familyName><degrees>FRACP</degrees></personName></creator><creator xml:id="au10" creatorRole="author" affiliationRef="#af10"><personName><givenNames>Vilho</givenNames><familyName>Myllyla</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au11" creatorRole="author" 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type="organization"><unparsedAffiliation>UCB Pharma GmbH, Monheim, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af17" countryCode="US" type="organization"><unparsedAffiliation>Schwarz Biosciences Inc, a member of the UCB Group, Raleigh, NC, USA</unparsedAffiliation></affiliation><affiliation xml:id="af18" countryCode="GB" type="organization"><unparsedAffiliation>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, London, United Kingdom</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">dopamine agonist</keyword><keyword xml:id="kwd2">rotigotine</keyword><keyword xml:id="kwd3">transdermal</keyword><keyword xml:id="kwd4">motor function</keyword><keyword xml:id="kwd5">sleep</keyword><keyword xml:id="kwd6">quality of life</keyword></keywordGroup><fundingInfo><fundingAgency>Schwarz Biosciences GmbH</fundingAgency></fundingInfo><fundingInfo><fundingAgency>UCB Group of Companies</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Schwarz Pharma Ltd, Ireland</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Global Publications Manager</fundingAgency></fundingInfo><fundingInfo><fundingAgency>UCB Pharma SA</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Evidence Scientific Solutions, Horsham, UK</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Isis Innovation Limited</fundingAgency></fundingInfo><supportingInformation><p> Additional Supporting Information may be found in the online version of this article. </p><supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds23441:MDS_23441_sm_suppinfo"></mediaResource><caption>Supporting Information</caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>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]; <i>P</i> = 0.0002) and PDSS‐2 (treatment difference: −4.26 [95% CI −6.08, −2.45]; <i>P</i> < 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. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn9"><p>Potential conflict of interest: All investigators received grant payments from Schwarz Biosciences GmbH, a member of the UCB group of companies, for enrolling patients into the study.</p></note><note xml:id="fn11"><p>Members of the “RECOVER Study Group” are listed as an <link href="#app1">Appendix</link>.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Rotigotine Recover Study</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)</title></titleInfo><name type="personal"><namePart type="given">Claudia</namePart><namePart type="family">Trenkwalder</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Clinical Neurophysiology, University of Goettingen and Paracelsus‐Elena Klinik, Kassel, Germany</affiliation><description>Correspondence: Department of Clinical Neurophysiology, University of Goettingen, and Paracelsus Elena‐Klinik, Center of Parkinsonism and Movement Disorders, Kassel, Klinikstrasse 16, Kassel, Germany</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bryan</namePart><namePart type="family">Kies</namePart><namePart type="termsOfAddress">FCNeurol (SA)</namePart><affiliation>Neurology Division, University of Cape Town, South Africa</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Monika</namePart><namePart type="family">Rudzinska</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Jagiellonian University Medical College, Krakow, Poland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jennifer</namePart><namePart type="family">Fine</namePart><namePart type="termsOfAddress">FCP (SA) Neurology</namePart><affiliation>Constantiaberg MediClinic, Cape Town, South Africa</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Janos</namePart><namePart type="family">Nikl</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Hospital of Zala County, Zalaegerszeg, Hungary</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Krystyna</namePart><namePart type="family">Honczarenko</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Clinic of Neurology, Pomeranian Medical University, Szczecin, Poland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peter</namePart><namePart type="family">Dioszeghy</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, County Hospital, Nyiregyhaza, Hungary</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Dennis</namePart><namePart type="family">Hill</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Central Carolina Neurology and Sleep, Salisbury, North Carolina, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Tim</namePart><namePart type="family">Anderson</namePart><namePart type="termsOfAddress">FRACP</namePart><affiliation>Department of Medicine, University of Otago, Christchurch, and Van Der Veer Institute, Christchurch, New Zealand</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Vilho</namePart><namePart type="family">Myllyla</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Oulu University Hospital, Oulu, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jan</namePart><namePart type="family">Kassubek</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neurologische Klinik, Universität Ulm, Ulm, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Malcolm</namePart><namePart type="family">Steiger</namePart><namePart type="termsOfAddress">FRCP</namePart><affiliation>The Walton Centre of Neurology and Neurosurgery, Liverpool, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marco</namePart><namePart type="family">Zucconi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Centro per i Disturbi del Sonno, Instituto Scientifico H San Raffaele, Milan, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eduardo</namePart><namePart type="family">Tolosa</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Werner</namePart><namePart type="family">Poewe</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Erwin</namePart><namePart type="family">Surmann</namePart><namePart type="termsOfAddress">MSc</namePart><affiliation>UCB Pharma GmbH, Monheim, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">John</namePart><namePart type="family">Whitesides</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Schwarz Biosciences Inc, a member of the UCB Group, Raleigh, NC, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Babak</namePart><namePart type="family">Boroojerdi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>UCB Pharma GmbH, Monheim, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kallol Ray</namePart><namePart type="family">Chaudhuri</namePart><namePart type="termsOfAddress">DSc</namePart><affiliation>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, London, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart>the RECOVER Study Group</namePart><namePart type="family">the RECOVER Study Group</namePart><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2011-01</dateIssued><dateCaptured encoding="w3cdtf">2010-06-22</dateCaptured><dateValid encoding="w3cdtf">2010-08-27</dateValid><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">3</extent><extent unit="tables">3</extent><extent unit="references">30</extent><extent unit="words">7061</extent></physicalDescription><abstract lang="en">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. © 2010 Movement Disorder Society</abstract><note type="content">*Potential conflict of interest: All investigators received grant payments from Schwarz Biosciences GmbH, a member of the UCB group of companies, for enrolling patients into the study.</note><note type="content">*Members of the “RECOVER Study Group” are listed as an Appendix.</note><note type="funding">Schwarz Biosciences GmbH</note><note type="funding">UCB Group of Companies</note><note type="funding">Schwarz Pharma Ltd, Ireland</note><note type="funding">Global Publications Manager</note><note type="funding">UCB Pharma SA</note><note type="funding">Evidence Scientific Solutions, Horsham, UK</note><note type="funding">Isis Innovation Limited</note><subject lang="en"><genre>Keywords</genre><topic>dopamine agonist</topic><topic>rotigotine</topic><topic>transdermal</topic><topic>motor function</topic><topic>sleep</topic><topic>quality of life</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><note type="content"> Additional Supporting Information may be found in the online version of this article.Supporting Info Item: Supporting Information - </note><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>26</number></detail><detail type="issue"><caption>no.</caption><number>1</number></detail><extent unit="pages"><start>90</start><end>99</end><total>10</total></extent></part></relatedItem><identifier type="istex">5E16E1D432ED9110E7448651B48C08D89C1CCA1B</identifier><identifier type="DOI">10.1002/mds.23441</identifier><identifier type="ArticleID">MDS23441</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2010 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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