Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial.
Identifieur interne : 000082 ( PubMed/Curation ); précédent : 000081; suivant : 000083Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial.
Auteurs : William. Marks [États-Unis] ; Raymond. Bartus ; Joao Siffert ; Charles. Davis ; Andres Lozano ; Nicholas Boulis ; Jerrold Vitek ; Mark Stacy ; Dennis Turner ; Leonard Verhagen ; Roy Bakay ; Raymond Watts ; Barton Guthrie ; Joseph Jankovic ; Richard Simpson ; Michele Tagliati ; Ron Alterman ; Matthew Stern ; Gordon Baltuch ; Philip. Starr ; Paul. Larson ; Jill. Ostrem ; John Nutt ; Karl Kieburtz ; Jeffrey. Kordower ; C OlanowSource :
- The Lancet. Neurology ; 2010.
English descriptors
- KwdEn :
- Adult, Aged, Analysis of Variance, Dependovirus (genetics), Dependovirus (physiology), Double-Blind Method, Female, Follow-Up Studies, Genetic Therapy (methods), Humans, Male, Middle Aged, Motor Activity (physiology), Neurturin (genetics), Neurturin (metabolism), Neurturin (therapeutic use), Parkinson Disease (genetics), Parkinson Disease (physiopathology), Parkinson Disease (therapy), Putamen (metabolism), Putamen (physiology), Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , genetics : Neurturin.
- genetics : Dependovirus, Parkinson Disease.
- chemical , metabolism : Neurturin, Putamen.
- methods : Genetic Therapy.
- physiology : Dependovirus, Motor Activity, Putamen.
- physiopathology : Parkinson Disease.
- chemical , therapeutic use : Neurturin.
- therapy : Parkinson Disease.
- Adult, Aged, Analysis of Variance, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
In an open-label phase 1 trial, gene delivery of the trophic factor neurturin via an adeno-associated type-2 vector (AAV2) was well tolerated and seemed to improve motor function in patients with advanced Parkinson's disease. We aimed to assess the safety and efficacy of AAV2-neurturin in a double-blind, phase 2 randomised trial.
DOI: 10.1016/S1474-4422(10)70254-4
PubMed: 20970382
Links toward previous steps (curation, corpus...)
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Links to Exploration step
pubmed:20970382Le document en format XML
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Kordower</name></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C" last="Olanow">C Olanow</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="doi">10.1016/S1474-4422(10)70254-4</idno><idno type="RBID">pubmed:20970382</idno><idno type="pmid">20970382</idno><idno type="wicri:Area/PubMed/Corpus">000082</idno><idno type="wicri:Area/PubMed/Curation">000082</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial.</title><author><name sortKey="Marks, William J" sort="Marks, William J" uniqKey="Marks W" first="William" last="Marks">William. Marks</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of California San Francisco, San Francisco, CA</wicri:regionArea></affiliation></author><author><name sortKey="Bartus, Raymond T" sort="Bartus, Raymond T" uniqKey="Bartus R" first="Raymond" last="Bartus">Raymond. Bartus</name></author><author><name sortKey="Siffert, Joao" sort="Siffert, Joao" uniqKey="Siffert J" first="Joao" last="Siffert">Joao Siffert</name></author><author><name sortKey="Davis, Charles S" sort="Davis, Charles S" uniqKey="Davis C" first="Charles" last="Davis">Charles. Davis</name></author><author><name sortKey="Lozano, Andres" sort="Lozano, Andres" uniqKey="Lozano A" first="Andres" last="Lozano">Andres Lozano</name></author><author><name sortKey="Boulis, Nicholas" sort="Boulis, Nicholas" uniqKey="Boulis N" first="Nicholas" last="Boulis">Nicholas Boulis</name></author><author><name sortKey="Vitek, Jerrold" sort="Vitek, Jerrold" uniqKey="Vitek J" first="Jerrold" last="Vitek">Jerrold Vitek</name></author><author><name sortKey="Stacy, Mark" sort="Stacy, Mark" uniqKey="Stacy M" first="Mark" last="Stacy">Mark Stacy</name></author><author><name sortKey="Turner, Dennis" sort="Turner, Dennis" uniqKey="Turner D" first="Dennis" last="Turner">Dennis Turner</name></author><author><name sortKey="Verhagen, Leonard" sort="Verhagen, Leonard" uniqKey="Verhagen L" first="Leonard" last="Verhagen">Leonard Verhagen</name></author><author><name sortKey="Bakay, Roy" sort="Bakay, Roy" uniqKey="Bakay R" first="Roy" last="Bakay">Roy Bakay</name></author><author><name sortKey="Watts, Raymond" sort="Watts, Raymond" uniqKey="Watts R" first="Raymond" last="Watts">Raymond Watts</name></author><author><name sortKey="Guthrie, Barton" sort="Guthrie, Barton" uniqKey="Guthrie B" first="Barton" last="Guthrie">Barton Guthrie</name></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></author><author><name sortKey="Simpson, Richard" sort="Simpson, Richard" uniqKey="Simpson R" first="Richard" last="Simpson">Richard Simpson</name></author><author><name sortKey="Tagliati, Michele" sort="Tagliati, Michele" uniqKey="Tagliati M" first="Michele" last="Tagliati">Michele Tagliati</name></author><author><name sortKey="Alterman, Ron" sort="Alterman, Ron" uniqKey="Alterman R" first="Ron" last="Alterman">Ron Alterman</name></author><author><name sortKey="Stern, Matthew" sort="Stern, Matthew" uniqKey="Stern M" first="Matthew" last="Stern">Matthew Stern</name></author><author><name sortKey="Baltuch, Gordon" sort="Baltuch, Gordon" uniqKey="Baltuch G" first="Gordon" last="Baltuch">Gordon Baltuch</name></author><author><name sortKey="Starr, Philip A" sort="Starr, Philip A" uniqKey="Starr P" first="Philip" last="Starr">Philip. Starr</name></author><author><name sortKey="Larson, Paul S" sort="Larson, Paul S" uniqKey="Larson P" first="Paul" last="Larson">Paul. Larson</name></author><author><name sortKey="Ostrem, Jill L" sort="Ostrem, Jill L" uniqKey="Ostrem J" first="Jill" last="Ostrem">Jill. Ostrem</name></author><author><name sortKey="Nutt, John" sort="Nutt, John" uniqKey="Nutt J" first="John" last="Nutt">John Nutt</name></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name></author><author><name sortKey="Kordower, Jeffrey H" sort="Kordower, Jeffrey H" uniqKey="Kordower J" first="Jeffrey" last="Kordower">Jeffrey. Kordower</name></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C" last="Olanow">C Olanow</name></author></analytic><series><title level="j">The Lancet. Neurology</title><idno type="e-ISSN">1474-4465</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Analysis of Variance</term><term>Dependovirus (genetics)</term><term>Dependovirus (physiology)</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Genetic Therapy (methods)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Motor Activity (physiology)</term><term>Neurturin (genetics)</term><term>Neurturin (metabolism)</term><term>Neurturin (therapeutic use)</term><term>Parkinson Disease (genetics)</term><term>Parkinson Disease (physiopathology)</term><term>Parkinson Disease (therapy)</term><term>Putamen (metabolism)</term><term>Putamen (physiology)</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Neurturin</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Dependovirus</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Neurturin</term><term>Putamen</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Genetic Therapy</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Dependovirus</term><term>Motor Activity</term><term>Putamen</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Neurturin</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Analysis of Variance</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In an open-label phase 1 trial, gene delivery of the trophic factor neurturin via an adeno-associated type-2 vector (AAV2) was well tolerated and seemed to improve motor function in patients with advanced Parkinson's disease. We aimed to assess the safety and efficacy of AAV2-neurturin in a double-blind, phase 2 randomised trial.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">20970382</PMID><DateCreated><Year>2010</Year><Month>11</Month><Day>22</Day></DateCreated><DateCompleted><Year>2010</Year><Month>12</Month><Day>17</Day></DateCompleted><DateRevised><Year>2014</Year><Month>08</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4465</ISSN><JournalIssue CitedMedium="Internet"><Volume>9</Volume><Issue>12</Issue><PubDate><Year>2010</Year><Month>Dec</Month></PubDate></JournalIssue><Title>The Lancet. Neurology</Title><ISOAbbreviation>Lancet Neurol</ISOAbbreviation></Journal><ArticleTitle>Gene delivery of AAV2-neurturin for Parkinson's disease: a double-blind, randomised, controlled trial.</ArticleTitle><Pagination><MedlinePgn>1164-72</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(10)70254-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In an open-label phase 1 trial, gene delivery of the trophic factor neurturin via an adeno-associated type-2 vector (AAV2) was well tolerated and seemed to improve motor function in patients with advanced Parkinson's disease. We aimed to assess the safety and efficacy of AAV2-neurturin in a double-blind, phase 2 randomised trial.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We did a multicentre, double-blind, sham-surgery controlled trial in patients with advanced Parkinson's disease. Patients were randomly assigned (2:1) by a central, computer generated, randomisation code to receive either AAV2-neurturin (5·4 × 10¹¹ vector genomes) injected bilaterally into the putamen or sham surgery. All patients and study personnel with the exception of the neurosurgical team were masked to treatment assignment. The primary endpoint was change from baseline to 12 months in the motor subscore of the unified Parkinson's disease rating scale in the practically-defined off state. All randomly assigned patients who had at least one assessment after baseline were included in the primary analyses. This trial is registered at ClinicalTrials.gov, NCT00400634.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Between December, 2006, and November, 2008, 58 patients from nine sites in the USA participated in the trial. There was no significant difference in the primary endpoint in patients treated with AAV2-neurturin compared with control individuals (difference -0·31 [SE 2·63], 95% CI -5·58 to 4·97; p=0·91). Serious adverse events occurred in 13 of 38 patients treated with AAV2-neurturin and four of 20 control individuals. Three patients in the AAV2-neurturin group and two in the sham surgery group developed tumours.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Intraputaminal AAV2-neurturin is not superior to sham surgery when assessed using the UPDRS motor score at 12 months. However, the possibility of a benefit with additional targeting of the substantia nigra and longer term follow-up should be investigated in further studies.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Ceregene and Michael J Fox Foundation for Parkinson's Research.</AbstractText><CopyrightInformation>Copyright © 2010 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Marks</LastName><ForeName>William J</ForeName><Initials>WJ</Initials><Suffix>Jr</Suffix><AffiliationInfo><Affiliation>Department of Neurology, University of California San Francisco, San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bartus</LastName><ForeName>Raymond T</ForeName><Initials>RT</Initials></Author><Author ValidYN="Y"><LastName>Siffert</LastName><ForeName>Joao</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Davis</LastName><ForeName>Charles S</ForeName><Initials>CS</Initials></Author><Author ValidYN="Y"><LastName>Lozano</LastName><ForeName>Andres</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Boulis</LastName><ForeName>Nicholas</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Vitek</LastName><ForeName>Jerrold</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Stacy</LastName><ForeName>Mark</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Turner</LastName><ForeName>Dennis</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Verhagen</LastName><ForeName>Leonard</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Bakay</LastName><ForeName>Roy</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Watts</LastName><ForeName>Raymond</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Guthrie</LastName><ForeName>Barton</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Simpson</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Tagliati</LastName><ForeName>Michele</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Alterman</LastName><ForeName>Ron</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Stern</LastName><ForeName>Matthew</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Baltuch</LastName><ForeName>Gordon</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Starr</LastName><ForeName>Philip A</ForeName><Initials>PA</Initials></Author><Author ValidYN="Y"><LastName>Larson</LastName><ForeName>Paul S</ForeName><Initials>PS</Initials></Author><Author ValidYN="Y"><LastName>Ostrem</LastName><ForeName>Jill L</ForeName><Initials>JL</Initials></Author><Author ValidYN="Y"><LastName>Nutt</LastName><ForeName>John</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Kieburtz</LastName><ForeName>Karl</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Kordower</LastName><ForeName>Jeffrey H</ForeName><Initials>JH</Initials></Author><Author ValidYN="Y"><LastName>Olanow</LastName><ForeName>C Warren</ForeName><Initials>CW</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00400634</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2010</Year><Month>10</Month><Day>20</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Neurol</MedlineTA><NlmUniqueID>101139309</NlmUniqueID><ISSNLinking>1474-4422</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C495053">NRTN protein, human</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D051101">Neurturin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Lancet Neurol. 2010 Dec;9(12):1142-3</RefSource><PMID Version="1">21087733</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Curr Neurol Neurosci Rep. 2011 Aug;11(4):345-8</RefSource><PMID Version="1">21505812</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000704">Analysis of Variance</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000229">Dependovirus</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000235">genetics</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000502">physiology</QualifierName></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="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015316">Genetic Therapy</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000379">methods</QualifierName></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="D009043">Motor Activity</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000502">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D051101">Neurturin</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000235">genetics</QualifierName><QualifierName MajorTopicYN="N" UI="Q000378">metabolism</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000235">genetics</QualifierName><QualifierName MajorTopicYN="N" UI="Q000503">physiopathology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000628">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011699">Putamen</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000378">metabolism</QualifierName><QualifierName MajorTopicYN="N" UI="Q000502">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="aheadofprint"><Year>2010</Year><Month>10</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2010</Year><Month>10</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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