Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.
Identifieur interne : 000864 ( PubMed/Corpus ); précédent : 000863; suivant : 000865Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.
Auteurs : Yoshikuni Mizuno ; Masahiro Nomoto ; Tomoyoshi Kondo ; Kazuko Hasegawa ; Miho Murata ; Masahiro Takeuchi ; Junji Ikeda ; Takayuki Tomida ; Nobutaka HattoriSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2013.
English descriptors
- KwdEn :
- Administration, Cutaneous, Age Factors, Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Antiparkinson Agents (therapeutic use), Disease Progression, Double-Blind Method, Endpoint Determination, Female, Humans, Male, Middle Aged, Parkinson Disease (drug therapy), Tetrahydronaphthalenes (administration & dosage), Tetrahydronaphthalenes (adverse effects), Tetrahydronaphthalenes (therapeutic use), Thiophenes (administration & dosage), Thiophenes (adverse effects), Thiophenes (therapeutic use).
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Tetrahydronaphthalenes, Thiophenes.
- chemical , adverse effects : Antiparkinson Agents, Tetrahydronaphthalenes, Thiophenes.
- chemical , therapeutic use : Antiparkinson Agents, Tetrahydronaphthalenes, Thiophenes.
- drug therapy : Parkinson Disease.
- Administration, Cutaneous, Age Factors, Aged, Disease Progression, Double-Blind Method, Endpoint Determination, Female, Humans, Male, Middle Aged.
Abstract
We conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan.
DOI: 10.1002/mds.25537
PubMed: 23801585
Links to Exploration step
pubmed:23801585Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.</title><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><nlm:affiliation>Department of Neuroregeneration, Kitasato University School of Medicine, Sagamihara, Japan.</nlm:affiliation></affiliation></author><author><name sortKey="Nomoto, Masahiro" sort="Nomoto, Masahiro" uniqKey="Nomoto M" first="Masahiro" last="Nomoto">Masahiro Nomoto</name></author><author><name sortKey="Kondo, Tomoyoshi" sort="Kondo, Tomoyoshi" uniqKey="Kondo T" first="Tomoyoshi" last="Kondo">Tomoyoshi Kondo</name></author><author><name sortKey="Hasegawa, Kazuko" sort="Hasegawa, Kazuko" uniqKey="Hasegawa K" first="Kazuko" last="Hasegawa">Kazuko Hasegawa</name></author><author><name sortKey="Murata, Miho" sort="Murata, Miho" uniqKey="Murata M" first="Miho" last="Murata">Miho Murata</name></author><author><name sortKey="Takeuchi, Masahiro" sort="Takeuchi, Masahiro" uniqKey="Takeuchi M" first="Masahiro" last="Takeuchi">Masahiro Takeuchi</name></author><author><name sortKey="Ikeda, Junji" sort="Ikeda, Junji" uniqKey="Ikeda J" first="Junji" last="Ikeda">Junji Ikeda</name></author><author><name sortKey="Tomida, Takayuki" sort="Tomida, Takayuki" uniqKey="Tomida T" first="Takayuki" last="Tomida">Takayuki Tomida</name></author><author><name sortKey="Hattori, Nobutaka" sort="Hattori, Nobutaka" uniqKey="Hattori N" first="Nobutaka" last="Hattori">Nobutaka Hattori</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2013">2013</date><idno type="RBID">pubmed:23801585</idno><idno type="pmid">23801585</idno><idno type="doi">10.1002/mds.25537</idno><idno type="wicri:Area/PubMed/Corpus">000864</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.</title><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><nlm:affiliation>Department of Neuroregeneration, Kitasato University School of Medicine, Sagamihara, Japan.</nlm:affiliation></affiliation></author><author><name sortKey="Nomoto, Masahiro" sort="Nomoto, Masahiro" uniqKey="Nomoto M" first="Masahiro" last="Nomoto">Masahiro Nomoto</name></author><author><name sortKey="Kondo, Tomoyoshi" sort="Kondo, Tomoyoshi" uniqKey="Kondo T" first="Tomoyoshi" last="Kondo">Tomoyoshi Kondo</name></author><author><name sortKey="Hasegawa, Kazuko" sort="Hasegawa, Kazuko" uniqKey="Hasegawa K" first="Kazuko" last="Hasegawa">Kazuko Hasegawa</name></author><author><name sortKey="Murata, Miho" sort="Murata, Miho" uniqKey="Murata M" first="Miho" last="Murata">Miho Murata</name></author><author><name sortKey="Takeuchi, Masahiro" sort="Takeuchi, Masahiro" uniqKey="Takeuchi M" first="Masahiro" last="Takeuchi">Masahiro Takeuchi</name></author><author><name sortKey="Ikeda, Junji" sort="Ikeda, Junji" uniqKey="Ikeda J" first="Junji" last="Ikeda">Junji Ikeda</name></author><author><name sortKey="Tomida, Takayuki" sort="Tomida, Takayuki" uniqKey="Tomida T" first="Takayuki" last="Tomida">Takayuki Tomida</name></author><author><name sortKey="Hattori, Nobutaka" sort="Hattori, Nobutaka" uniqKey="Hattori N" first="Nobutaka" last="Hattori">Nobutaka Hattori</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2013" type="published">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Cutaneous</term><term>Age Factors</term><term>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Endpoint Determination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Tetrahydronaphthalenes (administration & dosage)</term><term>Tetrahydronaphthalenes (adverse effects)</term><term>Tetrahydronaphthalenes (therapeutic use)</term><term>Thiophenes (administration & dosage)</term><term>Thiophenes (adverse effects)</term><term>Thiophenes (therapeutic use)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Tetrahydronaphthalenes</term><term>Thiophenes</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Tetrahydronaphthalenes</term><term>Thiophenes</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</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" xml:lang="en"><term>Administration, Cutaneous</term><term>Age Factors</term><term>Aged</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Endpoint Determination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">23801585</PMID><DateCreated><Year>2013</Year><Month>09</Month><Day>30</Day></DateCreated><DateCompleted><Year>2014</Year><Month>05</Month><Day>09</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>28</Volume><Issue>10</Issue><PubDate><Year>2013</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.</ArticleTitle><Pagination><MedlinePgn>1447-50</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.25537</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">We conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Patients received once-daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The mean (± standard deviation) changes in UPDRS part II and III scores were -8.4 ± 9.7 in the rotigotine group and -4.1 ± 8.2 in the placebo group and were significantly different (P = 0.002). More patients in the rotigotine group than in the placebo group had a ≥ 20% score reduction. No serious drug-related adverse events were reported.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD.</AbstractText><CopyrightInformation>© 2013 International Parkinson and Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mizuno</LastName><ForeName>Yoshikuni</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Neuroregeneration, Kitasato University School of Medicine, Sagamihara, Japan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nomoto</LastName><ForeName>Masahiro</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Kondo</LastName><ForeName>Tomoyoshi</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Hasegawa</LastName><ForeName>Kazuko</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Murata</LastName><ForeName>Miho</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Takeuchi</LastName><ForeName>Masahiro</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Ikeda</LastName><ForeName>Junji</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Tomida</LastName><ForeName>Takayuki</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Hattori</LastName><ForeName>Nobutaka</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><CollectiveName>Rotigotine Trial Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>06</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</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>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000279">Administration, Cutaneous</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000367">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000978">Antiparkinson Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018450">Disease Progression</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D023381">Endpoint Determination</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></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013764">Tetrahydronaphthalenes</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013876">Thiophenes</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">early stage Parkinson's disease</Keyword><Keyword MajorTopicYN="N">randomized controlled trial</Keyword><Keyword MajorTopicYN="N">rotigotine</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Kimura</LastName><ForeName>Takashi</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Shoji</LastName><ForeName>Mikio</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Takahashi</LastName><ForeName>Satoshi</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Abe</LastName><ForeName>Takashi</ForeName><Initials>T</Initials></Investigator><Investigator 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ValidYN="Y"><LastName>Mizoguchi</LastName><ForeName>Kouichi</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ohashi</LastName><ForeName>Toshihiko</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Atsumi</LastName><ForeName>Tetsushi</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Inukai</LastName><ForeName>Akira</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sawada</LastName><ForeName>Hideyuki</ForeName><Initials>H</Initials></Investigator><Investigator ValidYN="Y"><LastName>Fujimura</LastName><ForeName>Harutoshi</ForeName><Initials>H</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mitsui</LastName><ForeName>Yoshiyuki</ForeName><Initials>Y</Initials></Investigator><Investigator ValidYN="Y"><LastName>Inui</LastName><ForeName>Toshio</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yamamoto</LastName><ForeName>Mitsutoshi</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Nagai</LastName><ForeName>Masahiro</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tsuboi</LastName><ForeName>Yoshio</ForeName><Initials>Y</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sasagasako</LastName><ForeName>Naokazu</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kondo</LastName><ForeName>Takayuki</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Katayama</LastName><ForeName>Souichi</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yokochi</LastName><ForeName>Fusako</ForeName><Initials>F</Initials></Investigator><Investigator ValidYN="Y"><LastName>Murakami</LastName><ForeName>Hidetomo</ForeName><Initials>H</Initials></Investigator><Investigator 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