Neuroprotection trials in Parkinson's disease: Systematic review
Identifieur interne : 000055 ( Main/Corpus ); précédent : 000054; suivant : 000056Neuroprotection trials in Parkinson's disease: Systematic review
Auteurs : Robert G. Hart ; Lesly A. Pearce ; Bernard M. Ravina ; Toby C. Yaltho ; John R. MarlerSource :
- Movement Disorders [ 0885-3185 ] ; 2009-04-15.
English descriptors
Abstract
Treatments to slow the progression are a major unmet need in Parkinson's disease. Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double‐blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO‐B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow‐up averaged <16 months in all but two trials. Detailed randomization methods and success of double‐blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. Future trials should include participants with wider ranges of disease stages and assess broader neurological outcomes. © 2008 Movement Disorder Society
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DOI: 10.1002/mds.22432
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Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double‐blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO‐B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow‐up averaged <16 months in all but two trials. Detailed randomization methods and success of double‐blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. Future trials should include participants with wider ranges of disease stages and assess broader neurological outcomes. © 2008 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Robert G. Hart MD</name><affiliations><json:string>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</json:string></affiliations></json:item><json:item><name>Lesly A. Pearce MS</name><affiliations><json:string>Minot, North Dakota, USA</json:string></affiliations></json:item><json:item><name>Bernard M. Ravina MD</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Toby C. Yaltho MD</name><affiliations><json:string>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</json:string></affiliations></json:item><json:item><name>John R. Marler MD</name><affiliations><json:string>National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, 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>neuroprotection</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>disease‐modifying</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clinical trial</value></json:item></subject><articleId><json:string>MDS22432</json:string></articleId><language><json:string>eng</json:string></language><abstract>Treatments to slow the progression are a major unmet need in Parkinson's disease. Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double‐blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO‐B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow‐up averaged >16 months in all but two trials. Detailed randomization methods and success of double‐blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. 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The CME activity including form, can be found online at http://www.movementdisorders.org/education/journalcme/</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Neuroprotection trials in Parkinson's disease: Systematic review</title><author><persName><forename type="first">Robert G.</forename><surname>Hart</surname></persName><roleName type="degree">MD</roleName><note type="correspondence"><p>Correspondence: Department of Neurology, University of Texas Health Science Center, 7703 Floyd Curl Drive, MC 7883, San Antonio, Texas 78229‐3900</p></note><affiliation>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</affiliation></author><author><persName><forename type="first">Lesly A.</forename><surname>Pearce</surname></persName><roleName type="degree">MS</roleName><affiliation>Minot, North Dakota, USA</affiliation></author><author><persName><forename type="first">Bernard M.</forename><surname>Ravina</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Toby C.</forename><surname>Yaltho</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</affiliation></author><author><persName><forename type="first">John R.</forename><surname>Marler</surname></persName><roleName type="degree">MD</roleName><affiliation>National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</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="2009-04-15"></date><biblScope unit="volume">24</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="647">647</biblScope><biblScope unit="page" to="654">654</biblScope></imprint></monogr><idno type="istex">8497F5F14173A746A749AFCA36A04C039BDD0BE0</idno><idno type="DOI">10.1002/mds.22432</idno><idno type="ArticleID">MDS22432</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2009</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Treatments to slow the progression are a major unmet need in Parkinson's disease. Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double‐blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO‐B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow‐up averaged <16 months in all but two trials. Detailed randomization methods and success of double‐blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. Future trials should include participants with wider ranges of disease stages and assess broader neurological outcomes. © 2008 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>neuroprotection</term></item><item><term>disease‐modifying</term></item><item><term>clinical trial</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Review</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2008-08-08">Received</change><change when="2008-11-23">Registration</change><change when="2009-04-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/8497F5F14173A746A749AFCA36A04C039BDD0BE0/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="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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date="2008-11-23"></event><event type="publishedOnlineEarlyUnpaginated" date="2008-12-31"></event><event type="firstOnline" date="2008-12-31"></event><event type="publishedOnlineFinalForm" date="2009-04-24"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.3.2 mode:FullText source:FullText result:FullText" date="2010-03-09"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-02"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-31"></event></eventGroup><numberingGroup><numbering type="pageFirst">647</numbering><numbering type="pageLast">654</numbering></numberingGroup><correspondenceTo>Department of Neurology, University of Texas Health Science Center, 7703 Floyd Curl Drive, MC 7883, San Antonio, Texas 78229‐3900</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS22432.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="0"></count><count type="tableTotal" number="4"></count><count type="referenceTotal" number="42"></count><count type="wordTotal" number="6995"></count></countGroup><titleGroup><title type="main" xml:lang="en">Neuroprotection trials in Parkinson's disease: Systematic review<link href="#fn1"></link> <link href="#fn20"></link></title><title type="short" xml:lang="en">Neuroprotection Trials in Parkinson's Disease</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Robert G.</givenNames><familyName>Hart</familyName><degrees>MD</degrees></personName><contactDetails><email>hartr@uthscsa.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Lesly A.</givenNames><familyName>Pearce</familyName><degrees>MS</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Bernard M.</givenNames><familyName>Ravina</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Toby C.</givenNames><familyName>Yaltho</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af4"><personName><givenNames>John R.</givenNames><familyName>Marler</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Minot, North Dakota, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Rochester School of Medicine, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">neuroprotection</keyword><keyword xml:id="kwd3">disease‐modifying</keyword><keyword xml:id="kwd4">clinical trial</keyword></keywordGroup><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:mds22432:mds22432app1"></mediaResource><caption>Appendix I: Description of individual clinical trials</caption></supportingInfoItem><supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds22432:mds22432app2"></mediaResource><caption>Appendix II: Design features of individual trials</caption></supportingInfoItem><supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds22432:mds22432app3"></mediaResource><caption>Appendix III. Change in total UPDRS score during follow‐up in placebo‐assigned patients</caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Treatments to slow the progression are a major unmet need in Parkinson's disease. Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double‐blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO‐B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow‐up averaged <16 months in all but two trials. Detailed randomization methods and success of double‐blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. Future trials should include participants with wider ranges of disease stages and assess broader neurological outcomes. © 2008 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Potential conflict of interest: The authors report no conflicts of interest.</p></note><note xml:id="fn20"><p>This article is part of the journal's online CME program. The CME activity including form, can be found online at <url href="http://www.movementdisorders.org/education/journalcme/">http://www.movementdisorders.org/education/journalcme/</url></p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Neuroprotection trials in Parkinson's disease: Systematic review</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Neuroprotection Trials in Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Neuroprotection trials in Parkinson's disease: Systematic review</title></titleInfo><name type="personal"><namePart type="given">Robert G.</namePart><namePart type="family">Hart</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</affiliation><description>Correspondence: Department of Neurology, University of Texas Health Science Center, 7703 Floyd Curl Drive, MC 7883, San Antonio, Texas 78229‐3900</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lesly A.</namePart><namePart type="family">Pearce</namePart><namePart type="termsOfAddress">MS</namePart><affiliation>Minot, North Dakota, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bernard M.</namePart><namePart type="family">Ravina</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Rochester School of Medicine, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Toby C.</namePart><namePart type="family">Yaltho</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Texas Health Science Center, San Antonio, Texas, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">John R.</namePart><namePart type="family">Marler</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="review-article" displayLabel="reviewArticle"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2009-04-15</dateIssued><dateCaptured encoding="w3cdtf">2008-08-08</dateCaptured><dateValid encoding="w3cdtf">2008-11-23</dateValid><copyrightDate encoding="w3cdtf">2009</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="tables">4</extent><extent unit="references">42</extent><extent unit="words">6995</extent></physicalDescription><abstract lang="en">Treatments to slow the progression are a major unmet need in Parkinson's disease. Detailed assessment of randomized trials testing putative neuroprotective drugs was undertaken to inform the design, reporting, and interpretation of future studies. This study is a systematic review of trials testing neuroprotective drugs. Data were extracted independently by two coauthors. Fifteen completed, published trials involving 4,087 participants tested 13 different drugs in 18 double‐blind comparisons with placebo. Seven comparisons involving 2,000 subjects assessed MAO‐B inhibitors. The primary outcome was change in the Unified Parkinson's Disease Rating Scale score in eight trials and time to need for dopaminergic therapy in seven. Mean participant age was 62 years, 35% were women, the interval from diagnosis to entry averaged 11 months, and the number of participants averaged 272 (largest = 806). Follow‐up averaged <16 months in all but two trials. Detailed randomization methods and success of double‐blinding were reported in 20% and 13%, respectively. Based on the investigators' conclusions, six trials were interpreted as consistent with a neuroprotective effect, three as negative, and five as either confounded or not meeting criteria for futility. Neuroprotection trials have involved relatively uniform groups of participants early in the clinical disease course, with outcomes weighted heavily toward motor deterioration. Future trials should include participants with wider ranges of disease stages and assess broader neurological outcomes. © 2008 Movement Disorder Society</abstract><note type="content">*Potential conflict of interest: The authors report no conflicts of interest.</note><note type="content">*This article is part of the journal's online CME program. The CME activity including form, can be found online at http://www.movementdisorders.org/education/journalcme/</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>neuroprotection</topic><topic>disease‐modifying</topic><topic>clinical trial</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></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: Appendix I: Description of individual clinical trials - Appendix II: Design features of individual trials - Appendix III. Change in total UPDRS score during follow‐up in placebo‐assigned patients - </note><subject><genre>article category</genre><topic>Review</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>2009</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>647</start><end>654</end><total>8</total></extent></part></relatedItem><identifier type="istex">8497F5F14173A746A749AFCA36A04C039BDD0BE0</identifier><identifier type="DOI">10.1002/mds.22432</identifier><identifier type="ArticleID">MDS22432</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2008 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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