Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study
Identifieur interne : 000100 ( Main/Corpus ); précédent : 000099; suivant : 000101Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study
Auteurs : Anthony H. V. Schapira ; Stefan Albrecht ; Paolo Barone ; Cynthia L. Comella ; Michael P. Mcdermott ; Yoshikuni Mizuno ; Werner Poewe ; Olivier Rascol ; Kenneth MarekSource :
- Movement Disorders [ 0885-3185 ] ; 2010-08-15.
English descriptors
Abstract
Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.23143
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Schapira</name><affiliation><mods:affiliation>Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Albrecht, Stefan" sort="Albrecht, Stefan" uniqKey="Albrecht S" first="Stefan" last="Albrecht">Stefan Albrecht</name><affiliation><mods:affiliation>Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim, Germany</mods:affiliation></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation><mods:affiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</mods:affiliation></affiliation></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. 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Comella</name><affiliation><mods:affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</mods:affiliation></affiliation></author><author><name sortKey="Mcdermott, Michael P" sort="Mcdermott, Michael P" uniqKey="Mcdermott M" first="Michael P." last="Mcdermott">Michael P. Mcdermott</name><affiliation><mods:affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><mods:affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</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, Innsbruck Medical University, Innsbruck, Austria</mods:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><mods:affiliation>Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Marek, Kenneth" sort="Marek, Kenneth" uniqKey="Marek K" first="Kenneth" last="Marek">Kenneth Marek</name><affiliation><mods:affiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</mods:affiliation></affiliation></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="2010-08-15">2010-08-15</date><biblScope unit="volume">25</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1627">1627</biblScope><biblScope unit="page" to="1632">1632</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">7B5F1EFF37468DE770370D07C19C11E1F8E02073</idno><idno type="DOI">10.1002/mds.23143</idno><idno type="ArticleID">MDS23143</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>clinical trial</term><term>delayed‐start</term><term>neuroprotection</term><term>pramipexole</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Anthony H.V. Schapira MD, DSc, FRCP, FMedSci</name><affiliations><json:string>Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</json:string></affiliations></json:item><json:item><name>Stefan Albrecht MD</name><affiliations><json:string>Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim, Germany</json:string></affiliations></json:item><json:item><name>Paolo Barone MD</name><affiliations><json:string>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</json:string></affiliations></json:item><json:item><name>Cynthia L. Comella MD</name><affiliations><json:string>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</json:string></affiliations></json:item><json:item><name>Michael P. McDermott PhD</name><affiliations><json:string>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Yoshikuni Mizuno MD</name><affiliations><json:string>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>Werner Poewe MD</name><affiliations><json:string>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</json:string></affiliations></json:item><json:item><name>Olivier Rascol MD, PhD</name><affiliations><json:string>Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse, France</json:string></affiliations></json:item><json:item><name>Kenneth Marek MD</name><affiliations><json:string>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>pramipexole</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>delayed‐start</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clinical trial</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>neuroprotection</value></json:item></subject><articleId><json:string>MDS23143</json:string></articleId><language><json:string>eng</json:string></language><abstract>Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society</abstract><qualityIndicators><score>6.773</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1567</abstractCharCount><pdfWordCount>3857</pdfWordCount><pdfCharCount>25709</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>243</abstractWordCount></qualityIndicators><title>Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD 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study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2010</date></publicationStmt><notesStmt><note type="content">*Potential conflict of interest: Each author has provided advice on a consultancy basis to BI.</note><note>Boehringer Inglheim</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study</title><author><persName><forename type="first">Anthony H.V.</forename><surname>Schapira</surname></persName><roleName type="degree">MD, DSc, FRCP, FMedSci</roleName><note type="correspondence"><p>Correspondence: University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, NW 3 2PF, UK</p></note><affiliation>Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</affiliation></author><author><persName><forename type="first">Stefan</forename><surname>Albrecht</surname></persName><roleName type="degree">MD</roleName><affiliation>Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim, Germany</affiliation></author><author><persName><forename type="first">Paolo</forename><surname>Barone</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</affiliation></author><author><persName><forename type="first">Cynthia L.</forename><surname>Comella</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation></author><author><persName><forename type="first">Michael P.</forename><surname>McDermott</surname></persName><roleName type="degree">PhD</roleName><affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Yoshikuni</forename><surname>Mizuno</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</affiliation></author><author><persName><forename type="first">Werner</forename><surname>Poewe</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</affiliation></author><author><persName><forename type="first">Olivier</forename><surname>Rascol</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse, France</affiliation></author><author><persName><forename type="first">Kenneth</forename><surname>Marek</surname></persName><roleName type="degree">MD</roleName><affiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>pramipexole</term></item><item><term>delayed‐start</term></item><item><term>clinical trial</term></item><item><term>neuroprotection</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="2009-11-13">Received</change><change when="2010-03-15">Registration</change><change when="2010-08-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/7B5F1EFF37468DE770370D07C19C11E1F8E02073/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. 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href="file:MDS.MDS23143.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="2"></count><count type="referenceTotal" number="33"></count><count type="wordTotal" number="4677"></count></countGroup><titleGroup><title type="main" xml:lang="en">Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study<link href="#fn3"></link></title><title type="short" xml:lang="en">PROUD Rationale and Delayed‐Start Design</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Anthony H.V.</givenNames><familyName>Schapira</familyName><degrees>MD, DSc, FRCP, FMedSci</degrees></personName><contactDetails><email>a.schapira@medsch.ucl.ac.uk</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Stefan</givenNames><familyName>Albrecht</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Paolo</givenNames><familyName>Barone</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Cynthia L.</givenNames><familyName>Comella</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Michael P.</givenNames><familyName>McDermott</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Yoshikuni</givenNames><familyName>Mizuno</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Werner</givenNames><familyName>Poewe</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Olivier</givenNames><familyName>Rascol</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af9"><personName><givenNames>Kenneth</givenNames><familyName>Marek</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="GB" type="organization"><unparsedAffiliation>Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="DE" type="organization"><unparsedAffiliation>Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="JP" type="organization"><unparsedAffiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="AT" type="organization"><unparsedAffiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="FR" type="organization"><unparsedAffiliation>Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse, France</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="US" type="organization"><unparsedAffiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">pramipexole</keyword><keyword xml:id="kwd3">delayed‐start</keyword><keyword xml:id="kwd4">clinical trial</keyword><keyword xml:id="kwd5">neuroprotection</keyword></keywordGroup><fundingInfo><fundingAgency>Boehringer Inglheim</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn3"><p>Potential conflict of interest: Each author has provided advice on a consultancy basis to BI.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>PROUD Rationale and Delayed‐Start Design</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study</title></titleInfo><name type="personal"><namePart type="given">Anthony H.V.</namePart><namePart type="family">Schapira</namePart><namePart type="termsOfAddress">MD, DSc, FRCP, FMedSci</namePart><affiliation>Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</affiliation><description>Correspondence: University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, NW 3 2PF, UK</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Stefan</namePart><namePart type="family">Albrecht</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Paolo</namePart><namePart type="family">Barone</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cynthia L.</namePart><namePart type="family">Comella</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michael P.</namePart><namePart type="family">McDermott</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Yoshikuni</namePart><namePart type="family">Mizuno</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</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, Innsbruck Medical University, Innsbruck, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Rascol</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kenneth</namePart><namePart type="family">Marek</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</affiliation><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">2010-08-15</dateIssued><dateCaptured encoding="w3cdtf">2009-11-13</dateCaptured><dateValid encoding="w3cdtf">2010-03-15</dateValid><copyrightDate encoding="w3cdtf">2010</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">1</extent><extent unit="tables">2</extent><extent unit="references">33</extent><extent unit="words">4677</extent></physicalDescription><abstract lang="en">Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double‐blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed‐start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6–9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I–III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub‐study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients. © 2010 Movement Disorder Society</abstract><note type="content">*Potential conflict of interest: Each author has provided advice on a consultancy basis to BI.</note><note type="funding">Boehringer Inglheim</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>pramipexole</topic><topic>delayed‐start</topic><topic>clinical trial</topic><topic>neuroprotection</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><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>2010</date><detail type="volume"><caption>vol.</caption><number>25</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1627</start><end>1632</end><total>6</total></extent></part></relatedItem><identifier type="istex">7B5F1EFF37468DE770370D07C19C11E1F8E02073</identifier><identifier type="DOI">10.1002/mds.23143</identifier><identifier type="ArticleID">MDS23143</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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