What is a clinically important change in the Unified Dyskinesia Rating Scale in Parkinson's disease?
Identifieur interne : 000347 ( PubMed/Checkpoint ); précédent : 000346; suivant : 000348What is a clinically important change in the Unified Dyskinesia Rating Scale in Parkinson's disease?
Auteurs : Tiago A. Mestre [Canada] ; Isabelle Beaulieu-Boire [Canada] ; Camila C. Aquino [Canada] ; Nicolas Phielipp [États-Unis] ; Yu Yan Poon [Canada] ; Jane P. Lui [Canada] ; Julie So [Canada] ; Susan H. Fox [Canada]Source :
- Parkinsonism & related disorders [ 1873-5126 ] ; 2015.
English descriptors
- KwdEn :
- Aged, Clinical Trials, Phase II as Topic, Dopamine Agents (administration & dosage), Dopamine Agents (pharmacology), Double-Blind Method, Dyskinesias (drug therapy), Female, Humans, Levodopa (administration & dosage), Levodopa (pharmacology), Male, Middle Aged, Parkinson Disease (drug therapy), Patient Outcome Assessment.
- MESH :
- chemical , administration & dosage : Dopamine Agents, Levodopa.
- chemical , pharmacology : Dopamine Agents, Levodopa.
- drug therapy : Dyskinesias, Parkinson Disease.
- Aged, Clinical Trials, Phase II as Topic, Double-Blind Method, Female, Humans, Male, Middle Aged, Patient Outcome Assessment.
Abstract
Dyskinesia remain a significant problem in Parkinson Disease (PD). The translation process of novel drug targets for dyskinesia has proven difficult with several failures at phase III level. Determining the 'clinically important change' (CIC) for dyskinesia rating scales in phase II clinical trials may assist in optimizing drug development of new anti-dyskinetic treatments. We used a standard phase IIa acute levodopa infusion paradigm to determine for the first time the CIC for dyskinesia using the new UDysRS.
DOI: 10.1016/j.parkreldis.2015.09.044
PubMed: 26439944
Affiliations:
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Mestre</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; The Parkinson's Disease and Movement Disorder Centre, Division of Neurology, Department of Medicine, The Ottawa Hospital, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. Electronic address: tmestre@toh.on.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; The Parkinson's Disease and Movement Disorder Centre, Division of Neurology, Department of Medicine, The Ottawa Hospital, The Ottawa Hospital Research Institute, Ottawa, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Beaulieu Boire, Isabelle" sort="Beaulieu Boire, Isabelle" uniqKey="Beaulieu Boire I" first="Isabelle" last="Beaulieu-Boire">Isabelle Beaulieu-Boire</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; Division of Neurology, Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, Québec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; Division of Neurology, Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, Québec</wicri:regionArea><wicri:noRegion>Québec</wicri:noRegion></affiliation></author><author><name sortKey="Aquino, Camila C" sort="Aquino, Camila C" uniqKey="Aquino C" first="Camila C" last="Aquino">Camila C. Aquino</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Phielipp, Nicolas" sort="Phielipp, Nicolas" uniqKey="Phielipp N" first="Nicolas" last="Phielipp">Nicolas Phielipp</name><affiliation wicri:level="2"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; Department of Neurology (Movement Disorders), University of California Irvine, Irvine, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; Department of Neurology (Movement Disorders), University of California Irvine, Irvine, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Poon, Yu Yan" sort="Poon, Yu Yan" uniqKey="Poon Y" first="Yu Yan" last="Poon">Yu Yan Poon</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Lui, Jane P" sort="Lui, Jane P" uniqKey="Lui J" first="Jane P" last="Lui">Jane P. Lui</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; University Health Network, Toronto Western Hospital, Department of Pharmacy, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; University Health Network, Toronto Western Hospital, Department of Pharmacy, Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="So, Julie" sort="So, Julie" uniqKey="So J" first="Julie" last="So">Julie So</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Fox, Susan H" sort="Fox, Susan H" uniqKey="Fox S" first="Susan H" last="Fox">Susan H. Fox</name><affiliation wicri:level="1"><nlm:affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author></analytic><series><title level="j">Parkinsonism & related disorders</title><idno type="eISSN">1873-5126</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Clinical Trials, Phase II as Topic</term><term>Dopamine Agents (administration & dosage)</term><term>Dopamine Agents (pharmacology)</term><term>Double-Blind Method</term><term>Dyskinesias (drug therapy)</term><term>Female</term><term>Humans</term><term>Levodopa (administration & dosage)</term><term>Levodopa (pharmacology)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Patient Outcome Assessment</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Dopamine Agents</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Dopamine Agents</term><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dyskinesias</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Clinical Trials, Phase II as Topic</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Patient Outcome Assessment</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Dyskinesia remain a significant problem in Parkinson Disease (PD). The translation process of novel drug targets for dyskinesia has proven difficult with several failures at phase III level. Determining the 'clinically important change' (CIC) for dyskinesia rating scales in phase II clinical trials may assist in optimizing drug development of new anti-dyskinetic treatments. We used a standard phase IIa acute levodopa infusion paradigm to determine for the first time the CIC for dyskinesia using the new UDysRS.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26439944</PMID><DateCreated><Year>2015</Year><Month>11</Month><Day>03</Day></DateCreated><DateCompleted><Year>2016</Year><Month>09</Month><Day>06</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>03</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-5126</ISSN><JournalIssue CitedMedium="Internet"><Volume>21</Volume><Issue>11</Issue><PubDate><Year>2015</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Parkinsonism & related disorders</Title><ISOAbbreviation>Parkinsonism Relat. Disord.</ISOAbbreviation></Journal><ArticleTitle>What is a clinically important change in the Unified Dyskinesia Rating Scale in Parkinson's disease?</ArticleTitle><Pagination><MedlinePgn>1349-54</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.parkreldis.2015.09.044</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1353-8020(15)00435-6</ELocationID><Abstract><AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">Dyskinesia remain a significant problem in Parkinson Disease (PD). The translation process of novel drug targets for dyskinesia has proven difficult with several failures at phase III level. Determining the 'clinically important change' (CIC) for dyskinesia rating scales in phase II clinical trials may assist in optimizing drug development of new anti-dyskinetic treatments. We used a standard phase IIa acute levodopa infusion paradigm to determine for the first time the CIC for dyskinesia using the new UDysRS.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We performed a randomized, double-blind, placebo-controlled crossover study with eleven PD patients with stable bothersome dyskinesia. We used the following patient-reported clinically important events as CIC anchors: onset, maximum intensity, remission of dyskinesia. Objective dyskinesia scores using the UDysRS part III Impairment were determined at these same events by blinded video-rating. The CIC was determined using the 'within-patient' score change and a sensitivity- and specificity-based approach.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Patients were most aware of 'onset of dyskinesia', followed by 'remission of dyskinesia'. An 11.1-point median change (UDysRS Part III Impairment, p < 0.0001) was the CIC for patient-reported remission of dyskinesia from a practically defined-OFF state. A 2.32-point change (UDysRS Part III Impairment) had the best specificity and sensitivity to distinguish between patient-reported remission and perception of dyskinesia.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In this study, we provide the first report of a CIC for the UDysRS Part III Impairment. Early knowledge of a CIC may help inform the decision to advance into phase III trials and contribute for a higher yield of success in finding new anti-dyskinetic treatments.</AbstractText><CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mestre</LastName><ForeName>Tiago A</ForeName><Initials>TA</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; The Parkinson's Disease and Movement Disorder Centre, Division of Neurology, Department of Medicine, The Ottawa Hospital, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. Electronic address: tmestre@toh.on.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Beaulieu-Boire</LastName><ForeName>Isabelle</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; Division of Neurology, Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, Québec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aquino</LastName><ForeName>Camila C</ForeName><Initials>CC</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Phielipp</LastName><ForeName>Nicolas</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; Department of Neurology (Movement Disorders), University of California Irvine, Irvine, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poon</LastName><ForeName>Yu Yan</ForeName><Initials>YY</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lui</LastName><ForeName>Jane P</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada; University Health Network, Toronto Western Hospital, Department of Pharmacy, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>So</LastName><ForeName>Julie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fox</LastName><ForeName>Susan H</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>Movement Disorders Centre and Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital, University Health Network, Division of Neurology, University of Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></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>2015</Year><Month>09</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Parkinsonism Relat Disord</MedlineTA><NlmUniqueID>9513583</NlmUniqueID><ISSNLinking>1353-8020</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015259">Dopamine Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017322" MajorTopicYN="N">Clinical Trials, Phase II as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015259" MajorTopicYN="N">Dopamine Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020820" MajorTopicYN="N">Dyskinesias</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007980" MajorTopicYN="N">Levodopa</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D063868" MajorTopicYN="Y">Patient Outcome Assessment</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Clinical trial</Keyword><Keyword MajorTopicYN="N">Clinically important change</Keyword><Keyword MajorTopicYN="N">Dyskinesia</Keyword><Keyword MajorTopicYN="N">Minimally clinical important difference</Keyword><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">Treatment</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>07</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>09</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>09</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>10</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>10</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>9</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26439944</ArticleId><ArticleId IdType="pii">S1353-8020(15)00435-6</ArticleId><ArticleId IdType="doi">10.1016/j.parkreldis.2015.09.044</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>États-Unis</li></country><region><li>Californie</li></region></list><tree><country name="Canada"><noRegion><name sortKey="Mestre, Tiago A" sort="Mestre, Tiago A" uniqKey="Mestre T" first="Tiago A" last="Mestre">Tiago A. Mestre</name></noRegion><name sortKey="Aquino, Camila C" sort="Aquino, Camila C" uniqKey="Aquino C" first="Camila C" last="Aquino">Camila C. Aquino</name><name sortKey="Beaulieu Boire, Isabelle" sort="Beaulieu Boire, Isabelle" uniqKey="Beaulieu Boire I" first="Isabelle" last="Beaulieu-Boire">Isabelle Beaulieu-Boire</name><name sortKey="Fox, Susan H" sort="Fox, Susan H" uniqKey="Fox S" first="Susan H" last="Fox">Susan H. Fox</name><name sortKey="Lui, Jane P" sort="Lui, Jane P" uniqKey="Lui J" first="Jane P" last="Lui">Jane P. Lui</name><name sortKey="Poon, Yu Yan" sort="Poon, Yu Yan" uniqKey="Poon Y" first="Yu Yan" last="Poon">Yu Yan Poon</name><name sortKey="So, Julie" sort="So, Julie" uniqKey="So J" first="Julie" last="So">Julie So</name></country><country name="États-Unis"><region name="Californie"><name sortKey="Phielipp, Nicolas" sort="Phielipp, Nicolas" uniqKey="Phielipp N" first="Nicolas" last="Phielipp">Nicolas Phielipp</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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