Long‐term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease
Identifieur interne : 001081 ( Istex/Corpus ); précédent : 001080; suivant : 001082Long‐term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease
Auteurs : Stewart A. Factor ; Kenneth Wolski ; Daniel M. Togasaki ; Susan Huyck ; Marc Cantillon ; T. W. Ho ; Robert A. Hauser ; Emmanuelle PourcherSource :
- Movement Disorders [ 0885-3185 ] ; 2013-06.
Abstract
Preladenant is a selective adenosine A2A receptor antagonist under investigation for Parkinson's disease treatment.
Url:
DOI: 10.1002/mds.25395
Links to Exploration step
ISTEX:8A122CC964B6F10850D78C925ED76802C5D82D14Le document en format XML
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Factor DO</name><affiliations><json:string>Emory University, Georgia, Atlanta, USA</json:string><json:string>E-mail: sfactor@emory.edu</json:string></affiliations></json:item><json:item><name>Kenneth Wolski MD</name><affiliations><json:string>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</json:string></affiliations></json:item><json:item><name>Daniel M. Togasaki MD, PhD</name><affiliations><json:string>University of Southern California, California, Los Angeles, USA</json:string></affiliations></json:item><json:item><name>Susan Huyck DrPH</name><affiliations><json:string>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</json:string></affiliations></json:item><json:item><name>Marc Cantillon MD</name><affiliations><json:string>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</json:string><json:string>Current Address: Wellness Managements Inc, New Jersey, Livingston, USA</json:string></affiliations></json:item><json:item><name>T.W. 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disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Ltd</publisher><availability><p>Copyright © 2013 Movement Disorder SocietyCopyright © 2013 Movement Disorder Society</p></availability><date>2013-01-30</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Long‐term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease</title><author xml:id="author-1"><persName><forename type="first">Stewart A.</forename><surname>Factor</surname></persName><roleName type="degree">DO</roleName><email>sfactor@emory.edu</email><affiliation>Emory University, Georgia, Atlanta, USA</affiliation></author><author xml:id="author-2"><persName><forename type="first">Kenneth</forename><surname>Wolski</surname></persName><roleName type="degree">MD</roleName><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation></author><author xml:id="author-3"><persName><forename type="first">Daniel M.</forename><surname>Togasaki</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>University of Southern California, California, Los Angeles, USA</affiliation></author><author xml:id="author-4"><persName><forename type="first">Susan</forename><surname>Huyck</surname></persName><roleName type="degree">DrPH</roleName><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation></author><author xml:id="author-5"><persName><forename type="first">Marc</forename><surname>Cantillon</surname></persName><roleName type="degree">MD</roleName><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation><affiliation>Current Address: Wellness Managements Inc, New Jersey, Livingston, USA</affiliation></author><author xml:id="author-6"><persName><forename type="first">T.W.</forename><surname>Ho</surname></persName><roleName type="degree">MD</roleName><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation><affiliation>Current Address: AstraZeneca Pharmaceuticals LP, Delaware, Wilmington, USA</affiliation></author><author xml:id="author-7"><persName><forename type="first">Robert A.</forename><surname>Hauser</surname></persName><roleName type="degree">MD, MBA</roleName><affiliation>University of South Florida, Florida, Tampa, USA</affiliation></author><author xml:id="author-8"><persName><forename type="first">Emmanuelle</forename><surname>Pourcher</surname></persName><roleName type="degree">MD</roleName><affiliation>Laval University, Quebec, Quebec City, Canada</affiliation></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>Blackwell Publishing Ltd</publisher><date type="published" when="2013-06"></date><biblScope unit="volume">28</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="817">817</biblScope><biblScope unit="page" to="820">820</biblScope></imprint></monogr><idno type="istex">8A122CC964B6F10850D78C925ED76802C5D82D14</idno><idno type="DOI">10.1002/mds.25395</idno><idno type="ArticleID">MDS25395</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013-01-30</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Preladenant is a selective adenosine A2A receptor antagonist under investigation for Parkinson's disease treatment.</p></abstract><abstract><p>A phase 2 36‐week open‐label follow‐up of a double‐blind study using preladenant 5 mg twice a day as a levodopa adjunct in 140 subjects with fluctuating Parkinson's disease was conducted. The primary end point was adverse event (AE) assessment. Secondary (efficacy) analyses included hours/day spent in OFF and ON states and dyskinesia prevalence/severity.</p></abstract><abstract><p>The 36‐week open‐label phase was completed by 106 of 140 subjects (76%). AE‐related treatment discontinuations occurred in 19 subjects (14%). Treatment‐emergent AEs, reported by ≥15% of subjects, were dyskinesia (33%) and constipation (19%). Preladenant 5 mg twice a day provided OFF time reductions (1.4–1.9 hours/day) and ON time increases (1.2–1.5 hours/day) throughout the 36‐week treatment relative to the baseline of the double‐blind study.</p></abstract><abstract><p>Long‐term preladenant treatment (5 mg twice a day) was generally well tolerated and provided sustained OFF time reductions and ON time increases. © 2013 Movement Disorder Society</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>adenosine A2A receptor antagonist</term></item><item><term>Parkinson's disease</term></item><item><term>fluctuations</term></item><item><term>OFF time</term></item><item><term>clinical trial</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Brief Report</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2012-10-19">Received</change><change when="2013-01-15">Registration</change><change when="2013-01-30">Created</change><change when="2013-06">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api-v5.istex.fr/document/8A122CC964B6F10850D78C925ED76802C5D82D14/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" xml:id="mds25395"><header><publicationMeta level="product"><doi origin="wiley" 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" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="60"><doi>10.1002/mds.v28.6</doi><copyright ownership="thirdParty">Copyright © 2013 Movement Disorder Society</copyright><numberingGroup><numbering type="journalVolume" number="28">28</numbering><numbering type="journalIssue">6</numbering></numberingGroup><coverDate startDate="2013-06">June 2013</coverDate></publicationMeta><publicationMeta level="unit" position="270" type="article" status="forIssue"><doi>10.1002/mds.25395</doi><idGroup><id type="unit" value="MDS25395"></id></idGroup><countGroup><count type="pageTotal" number="4"></count></countGroup><titleGroup><title type="articleCategory">Brief Report</title><title type="tocHeading1">Brief Reports</title></titleGroup><copyright ownership="thirdParty">Copyright © 2013 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2012-10-19"></event><event type="manuscriptRevised" date="2013-01-10"></event><event type="manuscriptAccepted" date="2013-01-15"></event><event type="xmlCreated" agent="Cenveo Publisher Services" date="2013-01-30"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.3.5 mode:FullText" date="2014-11-21"></event><event type="publishedOnlineEarlyUnpaginated" date="2013-04-15"></event><event type="publishedOnlineFinalForm" date="2013-06-25"></event><event type="firstOnline" date="2013-04-15"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-03"></event></eventGroup><numberingGroup><numbering type="pageFirst">817</numbering><numbering type="pageLast">820</numbering></numberingGroup><correspondenceTo>Correspondence to: Dr. Stewart A. Factor, Emory University School of Medicine, Department of Neurology, 1841 Clifton Road NE, Atlanta, GA 30329, USA; <email>sfactor@emory.edu</email></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS25395.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Long‐term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease</title><title type="short">Preladenant Long‐Term Safety and Efficacy</title><title type="shortAuthors">Factor et al</title></titleGroup><creators><creator affiliationRef="#mds25395-aff-0001" corresponding="yes" creatorRole="author" xml:id="mds25395-cr-0001"><personName><givenNames>Stewart A.</givenNames><familyName>Factor</familyName><degrees>DO</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0002" creatorRole="author" xml:id="mds25395-cr-0002"><personName><givenNames>Kenneth</givenNames><familyName>Wolski</familyName><degrees>MD</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0003" creatorRole="author" xml:id="mds25395-cr-0003"><personName><givenNames>Daniel M.</givenNames><familyName>Togasaki</familyName><degrees>MD, PhD</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0002" creatorRole="author" xml:id="mds25395-cr-0004"><personName><givenNames>Susan</givenNames><familyName>Huyck</familyName><degrees>DrPH</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0002" currentRef="#mds25395-aff-0006" creatorRole="author" xml:id="mds25395-cr-0005"><personName><givenNames>Marc</givenNames><familyName>Cantillon</familyName><degrees>MD</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0002" currentRef="#mds25395-aff-0007" creatorRole="author" xml:id="mds25395-cr-0006"><personName><givenNames>T.W.</givenNames><familyName>Ho</familyName><degrees>MD</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0004" creatorRole="author" xml:id="mds25395-cr-0007"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD, MBA</degrees></personName></creator><creator affiliationRef="#mds25395-aff-0005" creatorRole="author" xml:id="mds25395-cr-0008"><personName><givenNames>Emmanuelle</givenNames><familyName>Pourcher</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation countryCode="US" type="organization" xml:id="mds25395-aff-0001"><orgName>Emory University</orgName><address><city>Atlanta</city><countryPart>Georgia</countryPart><country>USA</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="mds25395-aff-0002"><orgName>Merck Sharp & Dohme Corp.</orgName><address><city>Whitehouse Station</city><countryPart>New Jersey</countryPart><country>USA</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="mds25395-aff-0003"><orgName>University of Southern California</orgName><address><city>Los Angeles</city><countryPart>California</countryPart><country>USA</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="mds25395-aff-0004"><orgName>University of South Florida</orgName><address><city>Tampa</city><countryPart>Florida</countryPart><country>USA</country></address></affiliation><affiliation countryCode="CA" type="organization" xml:id="mds25395-aff-0005"><orgName>Laval University</orgName><address><city>Quebec City</city><countryPart>Quebec</countryPart><country>Canada</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="mds25395-aff-0006"><orgName>Wellness Managements Inc</orgName><address><city>Livingston</city><countryPart>New Jersey</countryPart><country>USA</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="mds25395-aff-0007"><orgName>AstraZeneca Pharmaceuticals LP</orgName><address><city>Wilmington</city><countryPart>Delaware</countryPart><country>USA</country></address></affiliation></affiliationGroup><keywordGroup type="author"><keyword xml:id="mds25395-kwd-0001">adenosine A<sub>2A</sub> receptor antagonist</keyword><keyword xml:id="mds25395-kwd-0002">Parkinson's disease</keyword><keyword xml:id="mds25395-kwd-0003">fluctuations</keyword><keyword xml:id="mds25395-kwd-0004">OFF time</keyword><keyword xml:id="mds25395-kwd-0005">clinical trial</keyword></keywordGroup><abstractGroup><abstract type="main"><title type="main">ABSTRACT</title><section xml:id="mds25395-sec-0001"><title type="main">Background</title><p>Preladenant is a selective adenosine A<sub>2A</sub> receptor antagonist under investigation for Parkinson's disease treatment.</p></section><section xml:id="mds25395-sec-0002"><title type="main">Methods</title><p>A phase 2 36‐week open‐label follow‐up of a double‐blind study using preladenant 5 mg twice a day as a levodopa adjunct in 140 subjects with fluctuating Parkinson's disease was conducted. The primary end point was adverse event (AE) assessment. Secondary (efficacy) analyses included hours/day spent in OFF and ON states and dyskinesia prevalence/severity.</p></section><section xml:id="mds25395-sec-0003"><title type="main">Results</title><p>The 36‐week open‐label phase was completed by 106 of 140 subjects (76%). AE‐related treatment discontinuations occurred in 19 subjects (14%). Treatment‐emergent AEs, reported by ≥15% of subjects, were dyskinesia (33%) and constipation (19%). Preladenant 5 mg twice a day provided OFF time reductions (1.4–1.9 hours/day) and ON time increases (1.2–1.5 hours/day) throughout the 36‐week treatment relative to the baseline of the double‐blind study.</p></section><section xml:id="mds25395-sec-0004"><title type="main">Conclusions</title><p>Long‐term preladenant treatment (5 mg twice a day) was generally well tolerated and provided sustained OFF time reductions and ON time increases. © 2013 <i>Movement</i> Disorder Society</p></section></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="mds25395-note-0001"><p><b>Funding agencies:</b> The study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey.</p></note><note xml:id="mds25395-note-0002"><p><b>Relevant conflicts of interest/financial disclosures:</b> Stewart A. Factor has not received any remuneration in relation to preladenant from Schering‐Plough or Merck & Co., Inc. Susan Huyck is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey. Kenneth Wolski, T.W. Ho, and Marc Cantillon are former employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey. Robert A. Hauser has received remuneration for consultative and advisory services related to preladenant. Emmanuelle Pourcher has received honoraria for consultancy related to preladenant.</p></note><note xml:id="mds25395-note-0003"><p>Full financial disclosures and author roles may be found in the online version of this article.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Long‐term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Preladenant Long‐Term Safety and Efficacy</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Long‐term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Stewart A.</namePart><namePart type="family">Factor</namePart><namePart type="termsOfAddress">DO</namePart><affiliation>Emory University, Georgia, Atlanta, USA</affiliation><affiliation>E-mail: sfactor@emory.edu</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kenneth</namePart><namePart type="family">Wolski</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Daniel M.</namePart><namePart type="family">Togasaki</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>University of Southern California, California, Los Angeles, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Susan</namePart><namePart type="family">Huyck</namePart><namePart type="termsOfAddress">DrPH</namePart><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marc</namePart><namePart type="family">Cantillon</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation><affiliation>Current Address: Wellness Managements Inc, New Jersey, Livingston, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">T.W.</namePart><namePart type="family">Ho</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Merck Sharp & Dohme Corp., New Jersey, Whitehouse Station, USA</affiliation><affiliation>Current Address: AstraZeneca Pharmaceuticals LP, Delaware, Wilmington, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD, MBA</namePart><affiliation>University of South Florida, Florida, Tampa, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Emmanuelle</namePart><namePart type="family">Pourcher</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Laval University, Quebec, Quebec City, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><dateIssued encoding="w3cdtf">2013-06</dateIssued><dateCreated encoding="w3cdtf">2013-01-30</dateCreated><dateCaptured encoding="w3cdtf">2012-10-19</dateCaptured><dateValid encoding="w3cdtf">2013-01-15</dateValid><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Preladenant is a selective adenosine A2A receptor antagonist under investigation for Parkinson's disease treatment.</abstract><abstract>A phase 2 36‐week open‐label follow‐up of a double‐blind study using preladenant 5 mg twice a day as a levodopa adjunct in 140 subjects with fluctuating Parkinson's disease was conducted. The primary end point was adverse event (AE) assessment. Secondary (efficacy) analyses included hours/day spent in OFF and ON states and dyskinesia prevalence/severity.</abstract><abstract>The 36‐week open‐label phase was completed by 106 of 140 subjects (76%). AE‐related treatment discontinuations occurred in 19 subjects (14%). Treatment‐emergent AEs, reported by ≥15% of subjects, were dyskinesia (33%) and constipation (19%). Preladenant 5 mg twice a day provided OFF time reductions (1.4–1.9 hours/day) and ON time increases (1.2–1.5 hours/day) throughout the 36‐week treatment relative to the baseline of the double‐blind study.</abstract><abstract>Long‐term preladenant treatment (5 mg twice a day) was generally well tolerated and provided sustained OFF time reductions and ON time increases. © 2013 Movement Disorder Society</abstract><subject><genre>keywords</genre><topic>adenosine A2A receptor antagonist</topic><topic>Parkinson's disease</topic><topic>fluctuations</topic><topic>OFF time</topic><topic>clinical trial</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>Brief Report</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>2013</date><detail type="volume"><caption>vol.</caption><number>28</number></detail><detail type="issue"><caption>no.</caption><number>6</number></detail><extent unit="pages"><start>817</start><end>820</end><total>4</total></extent></part></relatedItem><identifier type="istex">8A122CC964B6F10850D78C925ED76802C5D82D14</identifier><identifier type="DOI">10.1002/mds.25395</identifier><identifier type="ArticleID">MDS25395</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2013 Movement Disorder SocietyCopyright © 2013 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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