Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.
Identifieur interne : 000152 ( PubMed/Checkpoint ); précédent : 000151; suivant : 000153Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.
Auteurs : Joseph Jankovic [États-Unis] ; Ray. Watts ; Wayne Martin ; Babak BoroojerdiSource :
- Archives of neurology [ 0003-9942 ] ; 2007.
English descriptors
- KwdEn :
- Activities of Daily Living, Administration, Cutaneous, Aged, Case-Control Studies, Dopamine Antagonists (administration & dosage), Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson Disease (epidemiology), Severity of Illness Index, Tetrahydronaphthalenes (administration & dosage), Thiophenes (administration & dosage).
- MESH :
- chemical , administration & dosage : Dopamine Antagonists, Tetrahydronaphthalenes, Thiophenes.
- drug therapy : Parkinson Disease.
- epidemiology : Parkinson Disease.
- Activities of Daily Living, Administration, Cutaneous, Aged, Case-Control Studies, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index.
Abstract
To assess the response to the rotigotine transdermal system (Neupro; Schwarz Pharma Ltd, Monheim, Germany), a nonergolinic dopamine agonist, in patients with early Parkinson disease.
DOI: 10.1001/archneur.64.5.676
PubMed: 17502466
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.</title><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="1"><nlm:affiliation>Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas 77030, USA. josephj@bcm.tmc.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas 77030</wicri:regionArea><wicri:noRegion>Texas 77030</wicri:noRegion><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Watts, Ray L" sort="Watts, Ray L" uniqKey="Watts R" first="Ray" last="Watts">Ray. Watts</name></author><author><name sortKey="Martin, Wayne" sort="Martin, Wayne" uniqKey="Martin W" first="Wayne" last="Martin">Wayne Martin</name></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1001/archneur.64.5.676</idno><idno type="RBID">pubmed:17502466</idno><idno type="pmid">17502466</idno><idno type="wicri:Area/PubMed/Corpus">000162</idno><idno type="wicri:Area/PubMed/Curation">000162</idno><idno type="wicri:Area/PubMed/Checkpoint">000152</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.</title><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="1"><nlm:affiliation>Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas 77030, USA. josephj@bcm.tmc.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas 77030</wicri:regionArea><wicri:noRegion>Texas 77030</wicri:noRegion><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Watts, Ray L" sort="Watts, Ray L" uniqKey="Watts R" first="Ray" last="Watts">Ray. Watts</name></author><author><name sortKey="Martin, Wayne" sort="Martin, Wayne" uniqKey="Martin W" first="Wayne" last="Martin">Wayne Martin</name></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name></author></analytic><series><title level="j">Archives of neurology</title><idno type="ISSN">0003-9942</idno><imprint><date when="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Activities of Daily Living</term><term>Administration, Cutaneous</term><term>Aged</term><term>Case-Control Studies</term><term>Dopamine Antagonists (administration & dosage)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (epidemiology)</term><term>Severity of Illness Index</term><term>Tetrahydronaphthalenes (administration & dosage)</term><term>Thiophenes (administration & dosage)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Dopamine Antagonists</term><term>Tetrahydronaphthalenes</term><term>Thiophenes</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Activities of Daily Living</term><term>Administration, Cutaneous</term><term>Aged</term><term>Case-Control Studies</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To assess the response to the rotigotine transdermal system (Neupro; Schwarz Pharma Ltd, Monheim, Germany), a nonergolinic dopamine agonist, in patients with early Parkinson disease.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">17502466</PMID><DateCreated><Year>2007</Year><Month>05</Month><Day>15</Day></DateCreated><DateCompleted><Year>2007</Year><Month>06</Month><Day>21</Day></DateCompleted><DateRevised><Year>2008</Year><Month>01</Month><Day>02</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0003-9942</ISSN><JournalIssue CitedMedium="Print"><Volume>64</Volume><Issue>5</Issue><PubDate><Year>2007</Year><Month>May</Month></PubDate></JournalIssue><Title>Archives of neurology</Title><ISOAbbreviation>Arch. Neurol.</ISOAbbreviation></Journal><ArticleTitle>Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.</ArticleTitle><Pagination><MedlinePgn>676-82</MedlinePgn></Pagination><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To assess the response to the rotigotine transdermal system (Neupro; Schwarz Pharma Ltd, Monheim, Germany), a nonergolinic dopamine agonist, in patients with early Parkinson disease.</AbstractText><AbstractText Label="DESIGN" NlmCategory="METHODS">Randomized, double-blind, multicenter, placebo-controlled study.</AbstractText><AbstractText Label="SETTING" NlmCategory="METHODS">Fifty sites in the United States and Canada.</AbstractText><AbstractText Label="PATIENTS" NlmCategory="METHODS">Two hundred seventy-seven patients with early Parkinson disease. Eligibility was assessed by means of routine clinical and neurological examinations. Patients were randomized 2:1 to receive either rotigotine therapy or placebo.</AbstractText><AbstractText Label="INTERVENTION" NlmCategory="METHODS">Treatment with the rotigotine transdermal system, 2, 4, or 6 mg during 24 hours, for 24 weeks.</AbstractText><AbstractText Label="MAIN OUTCOME MEASURE" NlmCategory="METHODS">Percentage of subjects achieving a 20% response or greater (reduction) as assessed with the Unified Parkinson Disease Rating Scale subtotal (parts II [activities of daily living] and III [motor function]) from baseline to the end of the maintenance phase.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Significant differences were observed between the rotigotine-treated and placebo groups for the 20% responder rate (48% for the rotigotine group and 19% for the placebo group; P<.001), least squares mean change in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (-941 for rotigotine vs -157 for placebo; P<.001), and percentage changes in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (-15.1% for rotigotine vs 7.3% for placebo; P<.001). Rotigotine treatment significantly increased the patients' Clinical Global Impression Scale scores (57% for rotigotine vs 30% for placebo; P<.001) and had a positive effect on their quality of life. The most common adverse events were application site reactions, nausea, and somnolence. Twenty-five (14%) of 181 patients in the rotigotine group withdrew from the study because of adverse effects.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The rotigotine transdermal system consistently demonstrated statistically significant and clinically relevant efficacy over placebo in patients with early Parkinson disease and was well tolerated.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas 77030, USA. josephj@bcm.tmc.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Watts</LastName><ForeName>Ray L</ForeName><Initials>RL</Initials></Author><Author ValidYN="Y"><LastName>Martin</LastName><ForeName>Wayne</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Boroojerdi</LastName><ForeName>Babak</ForeName><Initials>B</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Arch Neurol</MedlineTA><NlmUniqueID>0372436</NlmUniqueID><ISSNLinking>0003-9942</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018492">Dopamine Antagonists</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013764">Tetrahydronaphthalenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013876">Thiophenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>92206-54-7</RegistryNumber><NameOfSubstance UI="C047508">N 0437</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Arch Neurol. 2007 Dec;64(12):1800-1; author reply 1801</RefSource><PMID Version="1">18071051</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000203">Activities of Daily Living</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000279">Administration, Cutaneous</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016022">Case-Control Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018492">Dopamine Antagonists</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000453">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013764">Tetrahydronaphthalenes</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013876">Thiophenes</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2007</Year><Month>5</Month><Day>16</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2007</Year><Month>6</Month><Day>22</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2007</Year><Month>5</Month><Day>16</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pii">64/5/676</ArticleId><ArticleId IdType="doi">10.1001/archneur.64.5.676</ArticleId><ArticleId IdType="pubmed">17502466</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Texas</li></region><settlement><li>Houston</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><noCountry><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><name sortKey="Martin, Wayne" sort="Martin, Wayne" uniqKey="Martin W" first="Wayne" last="Martin">Wayne Martin</name><name sortKey="Watts, Ray L" sort="Watts, Ray L" uniqKey="Watts R" first="Ray" last="Watts">Ray. Watts</name></noCountry><country name="États-Unis"><region name="Texas"><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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