Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.
Identifieur interne : 001079 ( PubMed/Curation ); précédent : 001078; suivant : 001080Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.
Auteurs : Joseph Jankovic [États-Unis] ; Ray L. 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
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pubmed:17502466Le document en format XML
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<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>
</affiliation>
</author>
<author><name sortKey="Watts, Ray L" sort="Watts, Ray L" uniqKey="Watts R" first="Ray L" last="Watts">Ray L. Watts</name>
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<author><name sortKey="Martin, Wayne" sort="Martin, Wayne" uniqKey="Martin W" first="Wayne" last="Martin">Wayne Martin</name>
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<author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name>
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<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>
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<author><name sortKey="Watts, Ray L" sort="Watts, Ray L" uniqKey="Watts R" first="Ray L" last="Watts">Ray L. Watts</name>
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<author><name sortKey="Martin, Wayne" sort="Martin, Wayne" uniqKey="Martin W" first="Wayne" last="Martin">Wayne Martin</name>
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<author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name>
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<series><title level="j">Archives of neurology</title>
<idno type="ISSN">0003-9942</idno>
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<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>
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<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 Status="MEDLINE" Owner="NLM"><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>2016</Year>
<Month>11</Month>
<Day>24</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>
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<Author ValidYN="Y"><LastName>Boroojerdi</LastName>
<ForeName>Babak</ForeName>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
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<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Arch Neurol</MedlineTA>
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<CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Arch Neurol. 2007 Dec;64(12):1800-1; author reply 1801</RefSource>
<PMID Version="1">18071051</PMID>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000203" MajorTopicYN="N">Activities of Daily Living</DescriptorName>
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<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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<MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
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<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
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<MeshHeading><DescriptorName UI="D013876" MajorTopicYN="N">Thiophenes</DescriptorName>
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