Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease
Identifieur interne : 000844 ( Istex/Corpus ); précédent : 000843; suivant : 000845Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease
Auteurs : Juliana Bronzova ; Cristina Sampaio ; Robert A. Hauser ; Anthony E. Lang ; Olivier Rascol ; Ad Theeuwes ; Serge V. Van De Witte ; Guus Van ScharrenburgSource :
- Movement Disorders [ 0885-3185 ] ; 2010-04-30.
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Abstract
This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; −7.3 points), as compared with placebo (−3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.22948
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Hauser</name><affiliation><mods:affiliation>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name><affiliation><mods:affiliation>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</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 Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name><affiliation><mods:affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van De Witte, Serge V" sort="Van De Witte, Serge V" uniqKey="Van De Witte S" first="Serge V." last="Van De Witte">Serge V. Van De Witte</name><affiliation><mods:affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van Scharrenburg, Guus" sort="Van Scharrenburg, Guus" uniqKey="Van Scharrenburg G" first="Guus" last="Van Scharrenburg">Guus Van Scharrenburg</name><affiliation><mods:affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</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="2010-04-30">2010-04-30</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="738">738</biblScope><biblScope unit="page" to="746">746</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895</idno><idno type="DOI">10.1002/mds.22948</idno><idno type="ArticleID">MDS22948</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>monotherapy</term><term>pardoprunox</term><term>partial dopamine agonist</term><term>randomized controlled clinical trial</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; −7.3 points), as compared with placebo (−3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Juliana Bronzova MD</name><affiliations><json:string>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</json:string></affiliations></json:item><json:item><name>Cristina Sampaio MD, PhD</name><affiliations><json:string>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</json:string></affiliations></json:item><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Anthony E. Lang MD</name><affiliations><json:string>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</json:string></affiliations></json:item><json:item><name>Olivier Rascol MD</name><affiliations><json:string>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</json:string></affiliations></json:item><json:item><name>Ad Theeuwes MSc</name><affiliations><json:string>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</json:string></affiliations></json:item><json:item><name>Serge V. van de Witte PhD</name><affiliations><json:string>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</json:string></affiliations></json:item><json:item><name>Guus van Scharrenburg PhD</name><affiliations><json:string>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</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>partial dopamine agonist</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>monotherapy</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>pardoprunox</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>randomized controlled clinical trial</value></json:item></subject><language><json:string>eng</json:string></language><abstract>This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; −7.3 points), as compared with placebo (−3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P > 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society</abstract><qualityIndicators><score>7.182</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1430</abstractCharCount><pdfWordCount>4638</pdfWordCount><pdfCharCount>32544</pdfCharCount><pdfPageCount>9</pdfPageCount><abstractWordCount>212</abstractWordCount></qualityIndicators><title>Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease</title><corporate><json:item><name></name><affiliations><json:string>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</json:string><json:string>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</json:string><json:string>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</json:string><json:string>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</json:string><json:string>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</json:string></affiliations></json:item></corporate><genre><json:string>Serial article</json:string></genre><host><volume>25</volume><pages><total>9</total><last>746</last><first>738</first></pages><issn><json:string>0885-3185</json:string></issn><issue>6</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2010</publicationDate><copyrightDate>2010</copyrightDate><doi><json:string>10.1002/mds.22948</json:string></doi><id>0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2010</date></publicationStmt><notesStmt><note type="content">*Potential conflict of interest: This study was financially supported by Solvay Pharmaceuticals. JB, AT, SVvdW and GvS are employees of Solvay Pharmaceuticals. CS is chairperson, and RAH, AEL, and OR are members of the permanent Steering Committee on the development of pardoprunox and have received support as consultants to the entire pardoprunox programme.</note><note>Bruegel Study Group</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease</title><author><orgName>on behalf of the Bruegel Study Group</orgName><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation><affiliation>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</affiliation><affiliation>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</affiliation><affiliation>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</affiliation></author><author><persName><forename type="first">Juliana</forename><surname>Bronzova</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Solvay Pharmaceuticals BV, WWE B‐316, C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands</p></note><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation></author><author><persName><forename type="first">Cristina</forename><surname>Sampaio</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</affiliation></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname><roleName type="degree">MD</roleName></persName><affiliation>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</affiliation></author><author><persName><forename type="first">Anthony E.</forename><surname>Lang</surname><roleName type="degree">MD</roleName></persName><affiliation>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</affiliation></author><author><persName><forename type="first">Olivier</forename><surname>Rascol</surname><roleName type="degree">MD</roleName></persName><affiliation>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</affiliation></author><author><persName><forename type="first">Ad</forename><surname>Theeuwes</surname><roleName type="degree">MSc</roleName></persName><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation></author><author><persName><forename type="first">Serge V.</forename><surname>van de Witte</surname><roleName type="degree">PhD</roleName></persName><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation></author><author><persName><forename type="first">Guus</forename><surname>van Scharrenburg</surname><roleName type="degree">PhD</roleName></persName><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</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>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-04-30"></date><biblScope unit="vol">25</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="738">738</biblScope><biblScope unit="page" to="746">746</biblScope></imprint></monogr><idno type="istex">0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895</idno><idno type="DOI">10.1002/mds.22948</idno><idno type="ArticleID">MDS22948</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2010</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; −7.3 points), as compared with placebo (−3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 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>partial dopamine agonist</term></item><item><term>monotherapy</term></item><item><term>pardoprunox</term></item><item><term>randomized controlled clinical trial</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="2009-11-06">Received</change><change when="2009-11-12">Registration</change><change when="2010-04-30">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="60"><doi origin="wiley" registered="yes">10.1002/mds.v25:6</doi><numberingGroup><numbering type="journalVolume" number="25">25</numbering><numbering type="journalIssue">6</numbering></numberingGroup><coverDate startDate="2010-04-30">30 April 2010</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="110" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.22948</doi><idGroup><id type="unit" value="MDS22948"></id></idGroup><countGroup><count type="pageTotal" number="9"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2010 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2009-11-06"></event><event type="manuscriptRevised" date="2009-11-12"></event><event type="manuscriptAccepted" date="2009-11-12"></event><event type="firstOnline" date="2010-03-02"></event><event type="publishedOnlineFinalForm" date="2010-04-26"></event><event type="publishedOnlineAcceptedOrEarlyUnpaginated" date="2010-03-02"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.5.2 mode:FullText" date="2011-08-12"></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">738</numbering><numbering type="pageLast">746</numbering></numberingGroup><correspondenceTo>Solvay Pharmaceuticals BV, WWE B‐316, C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands</correspondenceTo><objectNameGroup><objectName elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS22948.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="34"></count><count type="wordTotal" number="6263"></count></countGroup><titleGroup><title type="main" xml:lang="en">Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease<link href="#fn8"></link></title><title type="short" xml:lang="en">Pardoprunox in Early Parkinson's Disease</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Juliana</givenNames><familyName>Bronzova</familyName><degrees>MD</degrees></personName><contactDetails><email>Juliana.Bronzova@solvay.com</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Cristina</givenNames><familyName>Sampaio</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Anthony E.</givenNames><familyName>Lang</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Olivier</givenNames><familyName>Rascol</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Ad</givenNames><familyName>Theeuwes</familyName><degrees>MSc</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Serge V.</givenNames><familyName>van de Witte</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Guus</givenNames><familyName>van Scharrenburg</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" noteRef="#fn10"><groupName>on behalf of the Bruegel Study Group </groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="NL" type="organization"><unparsedAffiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="PT" type="organization"><unparsedAffiliation>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="CA" type="organization"><unparsedAffiliation>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="FR" type="organization"><unparsedAffiliation>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">partial dopamine agonist</keyword><keyword xml:id="kwd3">monotherapy</keyword><keyword xml:id="kwd4">pardoprunox</keyword><keyword xml:id="kwd5">randomized controlled clinical trial</keyword></keywordGroup><fundingInfo><fundingAgency>Bruegel Study Group</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; −7.3 points), as compared with placebo (−3.0 points; <i>P</i> = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; <i>P</i> < 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn8"><p>Potential conflict of interest: This study was financially supported by Solvay Pharmaceuticals. JB, AT, SVvdW and GvS are employees of Solvay Pharmaceuticals. CS is chairperson, and RAH, AEL, and OR are members of the permanent Steering Committee on the development of pardoprunox and have received support as consultants to the entire pardoprunox programme.</p></note><note xml:id="fn10"><p>Members of the “Bruegel Study Group” are listed as an Appendix.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Pardoprunox in Early Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Juliana</namePart><namePart type="family">Bronzova</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation><description>Correspondence: Solvay Pharmaceuticals BV, WWE B‐316, C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cristina</namePart><namePart type="family">Sampaio</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</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</namePart><affiliation>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Anthony E.</namePart><namePart type="family">Lang</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</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</namePart><affiliation>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ad</namePart><namePart type="family">Theeuwes</namePart><namePart type="termsOfAddress">MSc</namePart><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Serge V.</namePart><namePart type="family">van de Witte</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Guus</namePart><namePart type="family">van Scharrenburg</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>on behalf of the Bruegel Study Group</namePart><affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands</affiliation><affiliation>Department of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, Portugal</affiliation><affiliation>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</affiliation><affiliation>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</affiliation><description>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The NetherlandsDepartment of Pharmacology, Faculdade de Medicina de Lisboa, Lisbon, PortugalDepartments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida, USADivision of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, CanadaDepartments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825, Toulouse, France</description></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2010-04-30</dateIssued><dateCaptured encoding="w3cdtf">2009-11-06</dateCaptured><dateValid encoding="w3cdtf">2009-11-12</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">2</extent><extent unit="tables">3</extent><extent unit="references">34</extent><extent unit="words">6263</extent></physicalDescription><abstract lang="en">This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9–45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti‐Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)‐Motor score was improved in pardoprunox‐treated patients (overall mean dose 23.8 mg/d; −7.3 points), as compared with placebo (−3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥30% reduction in UPDRS‐Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS‐activities of daily living (ADL) and ‐ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox‐treated patients (vs. 3/70, 4.3%, placebo‐treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof‐of‐concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD. © 2010 Movement Disorder Society</abstract><note type="content">*Potential conflict of interest: This study was financially supported by Solvay Pharmaceuticals. JB, AT, SVvdW and GvS are employees of Solvay Pharmaceuticals. CS is chairperson, and RAH, AEL, and OR are members of the permanent Steering Committee on the development of pardoprunox and have received support as consultants to the entire pardoprunox programme.</note><note type="funding">Bruegel Study Group</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>partial dopamine agonist</topic><topic>monotherapy</topic><topic>pardoprunox</topic><topic>randomized controlled clinical trial</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><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>6</number></detail><extent unit="pages"><start>738</start><end>746</end><total>9</total></extent></part></relatedItem><identifier type="istex">0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895</identifier><identifier type="DOI">10.1002/mds.22948</identifier><identifier type="ArticleID">MDS22948</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2010 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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