Rotigotine Effects on Early Morning Motor Function and Sleep in Parkinson's Disease: A Double-Blind, Randomized, Placebo-Controlled Study (RECOVER)
Identifieur interne : 001999 ( Main/Merge ); précédent : 001998; suivant : 001A00Rotigotine Effects on Early Morning Motor Function and Sleep in Parkinson's Disease: A Double-Blind, Randomized, Placebo-Controlled Study (RECOVER)
Auteurs : Claudia Trenkwalder [Allemagne] ; Bryan Kies [Afrique du Sud] ; Monika Rudzinska [Pologne] ; Jennifer Fine [Afrique du Sud] ; Janos Nikl [Hongrie] ; Krystyna Honczarenko [Pologne] ; Peter Dioszeghy [Hongrie] ; Dennis Hill [États-Unis] ; Tim Anderson [Nouvelle-Zélande] ; Vilho Myllyla [Finlande] ; Jan Kassubek [Allemagne] ; Malcolm Steiger [Royaume-Uni] ; Marco Zucconi [Italie] ; Eduardo Tolosa [Espagne] ; Werner Poewe [Autriche] ; Erwin Surmann [Allemagne] ; John Whitesides [États-Unis] ; Babak Boroojerdi [Allemagne] ; Kallol Ray Chaudhuri [Royaume-Uni]Source :
- Movement disorders [ 0885-3185 ] ; 2011.
Descripteurs français
- Pascal (Inist)
English descriptors
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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.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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 wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Neurophysiology, University of Goettingen and Paracelsus-Elena Klinik</s1><s2>Kassel</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Kassel</region><settlement type="city">Cassel (Hesse)</settlement></placeName></affiliation></author><author><name sortKey="Kies, Bryan" sort="Kies, Bryan" uniqKey="Kies B" first="Bryan" last="Kies">Bryan Kies</name><affiliation wicri:level="1"><inist:fA14 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aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Myllyla, Vilho" sort="Myllyla, Vilho" uniqKey="Myllyla V" first="Vilho" last="Myllyla">Vilho Myllyla</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Neurology, Oulu University Hospital</s1><s2>Oulu</s2><s3>FIN</s3><sZ>10 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Oulu</wicri:noRegion></affiliation></author><author><name sortKey="Kassubek, Jan" sort="Kassubek, Jan" uniqKey="Kassubek J" first="Jan" last="Kassubek">Jan Kassubek</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Neurologische Klinik, Universität Ulm</s1><s2>Ulm</s2><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName><orgName type="university">Université d'Ulm</orgName></affiliation></author><author><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>The Walton Centre of Neurology and Neurosurgery</s1><s2>Liverpool</s2><s3>GBR</s3><sZ>12 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>The Walton Centre of Neurology and Neurosurgery</wicri:noRegion></affiliation></author><author><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Centro per i Disturbi del Sonno, Instituto Scientifico H San Raffaele</s1><s2>Milan</s2><s3>ITA</s3><sZ>13 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona</s1><s3>ESP</s3><sZ>14 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Department of Neurology, Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>UCB Pharma GmbH</s1><s2>Monheim</s2><s3>DEU</s3><sZ>16 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion></affiliation></author><author><name sortKey="Whitesides, John" sort="Whitesides, John" uniqKey="Whitesides J" first="John" last="Whitesides">John Whitesides</name><affiliation wicri:level="2"><inist:fA14 i1="17"><s1>Schwarz Biosciences Inc, a member of the UCB Group</s1><s2>Raleigh, NC</s2><s3>USA</s3><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>UCB Pharma GmbH</s1><s2>Monheim</s2><s3>DEU</s3><sZ>16 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="18"><s1>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry</s1><s2>London</s2><s3>GBR</s3><sZ>19 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">11-0143218</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 11-0143218 INIST</idno><idno type="RBID">Pascal:11-0143218</idno><idno type="wicri:Area/PascalFrancis/Corpus">000739</idno><idno type="wicri:Area/PascalFrancis/Curation">002579</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000409</idno><idno type="wicri:doubleKey">0885-3185:2011:Trenkwalder C:rotigotine:effects:on</idno><idno type="wicri:Area/Main/Merge">001999</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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 wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Neurophysiology, University of Goettingen and Paracelsus-Elena Klinik</s1><s2>Kassel</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Kassel</region><settlement type="city">Cassel (Hesse)</settlement></placeName></affiliation></author><author><name sortKey="Kies, Bryan" sort="Kies, Bryan" uniqKey="Kies B" first="Bryan" last="Kies">Bryan Kies</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Neurology Division, University of Cape Town</s1><s3>ZAF</s3><sZ>2 aut.</sZ></inist:fA14><country>Afrique du Sud</country><wicri:noRegion>Neurology Division, University of Cape Town</wicri:noRegion></affiliation></author><author><name sortKey="Rudzinska, Monika" sort="Rudzinska, Monika" uniqKey="Rudzinska M" first="Monika" last="Rudzinska">Monika Rudzinska</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Neurology, Jagiellonian University Medical College</s1><s2>Krakow</s2><s3>POL</s3><sZ>3 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Krakow</wicri:noRegion></affiliation></author><author><name sortKey="Fine, Jennifer" sort="Fine, Jennifer" uniqKey="Fine J" first="Jennifer" last="Fine">Jennifer Fine</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Constantiaberg MediClinic</s1><s2>Cape Town</s2><s3>ZAF</s3><sZ>4 aut.</sZ></inist:fA14><country>Afrique du Sud</country><wicri:noRegion>Constantiaberg MediClinic</wicri:noRegion></affiliation></author><author><name sortKey="Nikl, Janos" sort="Nikl, Janos" uniqKey="Nikl J" first="Janos" last="Nikl">Janos Nikl</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Neurology, Hospital of Zala County</s1><s2>Zalaegerszeg</s2><s3>HUN</s3><sZ>5 aut.</sZ></inist:fA14><country>Hongrie</country><wicri:noRegion>Zalaegerszeg</wicri:noRegion></affiliation></author><author><name sortKey="Honczarenko, Krystyna" sort="Honczarenko, Krystyna" uniqKey="Honczarenko K" first="Krystyna" last="Honczarenko">Krystyna Honczarenko</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Clinic of Neurology, Pomeranian Medical University</s1><s2>Szczecin</s2><s3>POL</s3><sZ>6 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Szczecin</wicri:noRegion></affiliation></author><author><name sortKey="Dioszeghy, Peter" sort="Dioszeghy, Peter" uniqKey="Dioszeghy P" first="Peter" last="Dioszeghy">Peter Dioszeghy</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurology, County Hospital</s1><s2>Nyiregyhaza</s2><s3>HUN</s3><sZ>7 aut.</sZ></inist:fA14><country>Hongrie</country><wicri:noRegion>Nyiregyhaza</wicri:noRegion></affiliation></author><author><name sortKey="Hill, Dennis" sort="Hill, Dennis" uniqKey="Hill D" first="Dennis" last="Hill">Dennis Hill</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Central Carolina Neurology and Sleep</s1><s2>Salisbury, North Carolina</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Anderson, Tim" sort="Anderson, Tim" uniqKey="Anderson T" first="Tim" last="Anderson">Tim Anderson</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Medicine, University of Otago, Christchurch, and Van Der Veer Institute</s1><s2>Christchurch</s2><s3>NZL</s3><sZ>9 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Myllyla, Vilho" sort="Myllyla, Vilho" uniqKey="Myllyla V" first="Vilho" last="Myllyla">Vilho Myllyla</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Neurology, Oulu University Hospital</s1><s2>Oulu</s2><s3>FIN</s3><sZ>10 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Oulu</wicri:noRegion></affiliation></author><author><name sortKey="Kassubek, Jan" sort="Kassubek, Jan" uniqKey="Kassubek J" first="Jan" last="Kassubek">Jan Kassubek</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Neurologische Klinik, Universität Ulm</s1><s2>Ulm</s2><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName><orgName type="university">Université d'Ulm</orgName></affiliation></author><author><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>The Walton Centre of Neurology and Neurosurgery</s1><s2>Liverpool</s2><s3>GBR</s3><sZ>12 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>The Walton Centre of Neurology and Neurosurgery</wicri:noRegion></affiliation></author><author><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Centro per i Disturbi del Sonno, Instituto Scientifico H San Raffaele</s1><s2>Milan</s2><s3>ITA</s3><sZ>13 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona</s1><s3>ESP</s3><sZ>14 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Department of Neurology, Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>15 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>UCB Pharma GmbH</s1><s2>Monheim</s2><s3>DEU</s3><sZ>16 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion></affiliation></author><author><name sortKey="Whitesides, John" sort="Whitesides, John" uniqKey="Whitesides J" first="John" last="Whitesides">John Whitesides</name><affiliation wicri:level="2"><inist:fA14 i1="17"><s1>Schwarz Biosciences Inc, a member of the UCB Group</s1><s2>Raleigh, NC</s2><s3>USA</s3><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>UCB Pharma GmbH</s1><s2>Monheim</s2><s3>DEU</s3><sZ>16 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Monheim</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion><wicri:noRegion>UCB Pharma GmbH</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="18"><s1>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry</s1><s2>London</s2><s3>GBR</s3><sZ>19 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Dopamine agonist</term><term>Double blind study</term><term>Morning</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Placebo</term><term>Quality of life</term><term>Rotigotine</term><term>Sleep</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Rotigotine</term><term>Matin</term><term>Sommeil</term><term>Etude double insu</term><term>Placebo</term><term>Stimulant dopaminergique</term><term>Qualité de vie</term></keywords></textClass></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.</div></front></TEI><affiliations><list><country><li>Afrique du Sud</li><li>Allemagne</li><li>Autriche</li><li>Espagne</li><li>Finlande</li><li>Hongrie</li><li>Italie</li><li>Nouvelle-Zélande</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bade-Wurtemberg</li><li>Caroline du Nord</li><li>District de Kassel</li><li>District de Tübingen</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Lombardie</li><li>Tyrol (Land)</li></region><settlement><li>Cassel (Hesse)</li><li>Innsbruck</li><li>Londres</li><li>Milan</li><li>Ulm</li></settlement><orgName><li>Université d'Ulm</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name></region><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><name sortKey="Kassubek, Jan" sort="Kassubek, Jan" uniqKey="Kassubek J" first="Jan" last="Kassubek">Jan Kassubek</name><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name></country><country name="Afrique du Sud"><noRegion><name sortKey="Kies, Bryan" sort="Kies, Bryan" uniqKey="Kies B" first="Bryan" last="Kies">Bryan Kies</name></noRegion><name sortKey="Fine, Jennifer" sort="Fine, Jennifer" uniqKey="Fine J" first="Jennifer" last="Fine">Jennifer Fine</name></country><country name="Pologne"><noRegion><name sortKey="Rudzinska, Monika" sort="Rudzinska, Monika" uniqKey="Rudzinska M" first="Monika" last="Rudzinska">Monika Rudzinska</name></noRegion><name sortKey="Honczarenko, Krystyna" sort="Honczarenko, Krystyna" uniqKey="Honczarenko K" first="Krystyna" last="Honczarenko">Krystyna Honczarenko</name></country><country name="Hongrie"><noRegion><name sortKey="Nikl, Janos" sort="Nikl, Janos" uniqKey="Nikl J" first="Janos" last="Nikl">Janos Nikl</name></noRegion><name sortKey="Dioszeghy, Peter" sort="Dioszeghy, Peter" uniqKey="Dioszeghy P" first="Peter" last="Dioszeghy">Peter Dioszeghy</name></country><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Hill, Dennis" sort="Hill, Dennis" uniqKey="Hill D" first="Dennis" last="Hill">Dennis Hill</name></region><name sortKey="Whitesides, John" sort="Whitesides, John" uniqKey="Whitesides J" first="John" last="Whitesides">John Whitesides</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Anderson, Tim" sort="Anderson, Tim" uniqKey="Anderson T" first="Tim" last="Anderson">Tim Anderson</name></noRegion></country><country name="Finlande"><noRegion><name sortKey="Myllyla, Vilho" sort="Myllyla, Vilho" uniqKey="Myllyla V" first="Vilho" last="Myllyla">Vilho Myllyla</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name></noRegion><name sortKey="Chaudhuri, Kallol Ray" sort="Chaudhuri, Kallol Ray" uniqKey="Chaudhuri K" first="Kallol Ray" last="Chaudhuri">Kallol Ray Chaudhuri</name></country><country name="Italie"><region name="Lombardie"><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name></region></country><country name="Espagne"><noRegion><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></noRegion></country><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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