Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease.
Identifieur interne : 001185 ( PubMed/Curation ); précédent : 001184; suivant : 001186Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease.
Auteurs : Anthony E. Lang [Canada] ; Steven Gill ; Nik K. Patel ; Andres Lozano ; John G. Nutt ; Richard Penn ; David J. Brooks ; Gary Hotton ; Elena Moro ; Peter Heywood ; Matthew A. Brodsky ; Kim Burchiel ; Patrick Kelly ; Arif Dalvi ; Burton Scott ; Mark Stacy ; Dennis Turner ; V G Frederich Wooten ; William J. Elias ; Edward R. Laws ; Vijay Dhawan ; A Jon Stoessl ; James Matcham ; Robert J. Coffey ; Michael TraubSource :
- Annals of neurology [ 0364-5134 ] ; 2006.
English descriptors
- KwdEn :
- Adult, Analysis of Variance, Dihydroxyphenylalanine (metabolism), Dose-Response Relationship, Drug, Double-Blind Method, Drug Delivery Systems, Drug Evaluation, Female, Glial Cell Line-Derived Neurotrophic Factor (therapeutic use), Humans, Male, Middle Aged, Parkinson Disease (diagnostic imaging), Parkinson Disease (drug therapy), Parkinson Disease (metabolism), Positron-Emission Tomography (methods), Putamen (diagnostic imaging), Putamen (drug effects), Putamen (metabolism), Recombinant Proteins (therapeutic use), Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , metabolism : Dihydroxyphenylalanine.
- chemical , therapeutic use : Glial Cell Line-Derived Neurotrophic Factor, Recombinant Proteins.
- diagnostic imaging : Parkinson Disease, Putamen.
- drug effects : Putamen.
- drug therapy : Parkinson Disease.
- metabolism : Parkinson Disease, Putamen.
- methods : Positron-Emission Tomography.
- Adult, Analysis of Variance, Dose-Response Relationship, Drug, Double-Blind Method, Drug Delivery Systems, Drug Evaluation, Female, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
Glial cell line-derived neurotrophic factor (GDNF) exerts potent trophic influence on midbrain dopaminergic neurons. This randomized controlled clinical trial was designed to confirm initial clinical benefits observed in a small, open-label trial using intraputamenal (Ipu) infusion of recombinant human GDNF (liatermin).
DOI: 10.1002/ana.20737
PubMed: 16429411
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pubmed:16429411Le document en format XML
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Lang</name><affiliation wicri:level="1"><nlm:affiliation>Toronto Western Hospital, University of Toronto, Ontario, Canada. lang@uhnres.utoronto.ca</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Hospital, University of Toronto, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Gill, Steven" sort="Gill, Steven" uniqKey="Gill S" first="Steven" last="Gill">Steven Gill</name></author><author><name sortKey="Patel, Nik K" sort="Patel, Nik K" uniqKey="Patel N" first="Nik K" last="Patel">Nik K. Patel</name></author><author><name sortKey="Lozano, Andres" sort="Lozano, Andres" uniqKey="Lozano A" first="Andres" last="Lozano">Andres Lozano</name></author><author><name sortKey="Nutt, John G" sort="Nutt, John G" uniqKey="Nutt J" first="John G" last="Nutt">John G. Nutt</name></author><author><name sortKey="Penn, Richard" sort="Penn, Richard" uniqKey="Penn R" first="Richard" last="Penn">Richard Penn</name></author><author><name sortKey="Brooks, David J" sort="Brooks, David J" uniqKey="Brooks D" first="David J" last="Brooks">David J. Brooks</name></author><author><name sortKey="Hotton, Gary" sort="Hotton, Gary" uniqKey="Hotton G" first="Gary" last="Hotton">Gary Hotton</name></author><author><name sortKey="Moro, Elena" sort="Moro, Elena" uniqKey="Moro E" first="Elena" last="Moro">Elena Moro</name></author><author><name sortKey="Heywood, Peter" sort="Heywood, Peter" uniqKey="Heywood P" first="Peter" last="Heywood">Peter Heywood</name></author><author><name sortKey="Brodsky, Matthew A" sort="Brodsky, Matthew A" uniqKey="Brodsky M" first="Matthew A" last="Brodsky">Matthew A. Brodsky</name></author><author><name sortKey="Burchiel, Kim" sort="Burchiel, Kim" uniqKey="Burchiel K" first="Kim" last="Burchiel">Kim Burchiel</name></author><author><name sortKey="Kelly, Patrick" sort="Kelly, Patrick" uniqKey="Kelly P" first="Patrick" last="Kelly">Patrick Kelly</name></author><author><name sortKey="Dalvi, Arif" sort="Dalvi, Arif" uniqKey="Dalvi A" first="Arif" last="Dalvi">Arif Dalvi</name></author><author><name sortKey="Scott, Burton" sort="Scott, Burton" uniqKey="Scott B" first="Burton" last="Scott">Burton Scott</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="Wooten, V G Frederich" sort="Wooten, V G Frederich" uniqKey="Wooten V" first="V G Frederich" last="Wooten">V G Frederich Wooten</name></author><author><name sortKey="Elias, William J" sort="Elias, William J" uniqKey="Elias W" first="William J" last="Elias">William J. Elias</name></author><author><name sortKey="Laws, Edward R" sort="Laws, Edward R" uniqKey="Laws E" first="Edward R" last="Laws">Edward R. Laws</name></author><author><name sortKey="Dhawan, Vijay" sort="Dhawan, Vijay" uniqKey="Dhawan V" first="Vijay" last="Dhawan">Vijay Dhawan</name></author><author><name sortKey="Stoessl, A Jon" sort="Stoessl, A Jon" uniqKey="Stoessl A" first="A Jon" last="Stoessl">A Jon Stoessl</name></author><author><name sortKey="Matcham, James" sort="Matcham, James" uniqKey="Matcham J" first="James" last="Matcham">James Matcham</name></author><author><name sortKey="Coffey, Robert J" sort="Coffey, Robert J" uniqKey="Coffey R" first="Robert J" last="Coffey">Robert J. Coffey</name></author><author><name sortKey="Traub, Michael" sort="Traub, Michael" uniqKey="Traub M" first="Michael" last="Traub">Michael Traub</name></author></analytic><series><title level="j">Annals of neurology</title><idno type="ISSN">0364-5134</idno><imprint><date when="2006" type="published">2006</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Analysis of Variance</term><term>Dihydroxyphenylalanine (metabolism)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Delivery Systems</term><term>Drug Evaluation</term><term>Female</term><term>Glial Cell Line-Derived Neurotrophic Factor (therapeutic use)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (diagnostic imaging)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (metabolism)</term><term>Positron-Emission Tomography (methods)</term><term>Putamen (diagnostic imaging)</term><term>Putamen (drug effects)</term><term>Putamen (metabolism)</term><term>Recombinant Proteins (therapeutic use)</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Dihydroxyphenylalanine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Glial Cell Line-Derived Neurotrophic Factor</term><term>Recombinant Proteins</term></keywords><keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Parkinson Disease</term><term>Putamen</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Putamen</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Parkinson Disease</term><term>Putamen</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Positron-Emission Tomography</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Analysis of Variance</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Delivery Systems</term><term>Drug Evaluation</term><term>Female</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">Glial cell line-derived neurotrophic factor (GDNF) exerts potent trophic influence on midbrain dopaminergic neurons. This randomized controlled clinical trial was designed to confirm initial clinical benefits observed in a small, open-label trial using intraputamenal (Ipu) infusion of recombinant human GDNF (liatermin).</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">16429411</PMID><DateCreated><Year>2006</Year><Month>02</Month><Day>27</Day></DateCreated><DateCompleted><Year>2006</Year><Month>05</Month><Day>09</Day></DateCompleted><DateRevised><Year>2016</Year><Month>11</Month><Day>24</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0364-5134</ISSN><JournalIssue CitedMedium="Print"><Volume>59</Volume><Issue>3</Issue><PubDate><Year>2006</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Annals of neurology</Title><ISOAbbreviation>Ann. Neurol.</ISOAbbreviation></Journal><ArticleTitle>Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease.</ArticleTitle><Pagination><MedlinePgn>459-66</MedlinePgn></Pagination><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Glial cell line-derived neurotrophic factor (GDNF) exerts potent trophic influence on midbrain dopaminergic neurons. This randomized controlled clinical trial was designed to confirm initial clinical benefits observed in a small, open-label trial using intraputamenal (Ipu) infusion of recombinant human GDNF (liatermin).</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Thirty-four PD patients were randomized 1 to 1 to receive bilateral continuous Ipu infusion of liatermin 15 microg/putamen/day or placebo. The primary end point was the change in Unified Parkinson Disease Rating Scale (UPDRS) motor score in the practically defined off condition at 6 months. Secondary end points included other UPDRS scores, motor tests, dyskinesia ratings, patient diaries, and (18)F-dopa uptake.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At 6 months, mean percentage changes in "off" UPDRS motor score were -10.0% and -4.5% in the liatermin and placebo groups, respectively. This treatment difference was not significant (95% confidence interval, -23.0 to 12.0, p = 0.53). Secondary end point results were similar between the groups. A 32.5% treatment difference favoring liatermin in mean (18)F-dopa influx constant (p = 0.019) was observed. Serious, device-related adverse events required surgical repositioning of catheters in two patients and removal of devices in another. Neutralizing antiliatermin antibodies were detected in three patients (one on-study and two in the open-label extension).</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Liatermin did not confer the predetermined level of clinical benefit to patients with PD despite increased (18)F-dopa uptake. It is uncertain whether technical differences between this trial and positive open-label studies contributed in any way this negative outcome.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lang</LastName><ForeName>Anthony E</ForeName><Initials>AE</Initials><AffiliationInfo><Affiliation>Toronto Western Hospital, University of Toronto, Ontario, Canada. lang@uhnres.utoronto.ca</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gill</LastName><ForeName>Steven</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Nik K</ForeName><Initials>NK</Initials></Author><Author ValidYN="Y"><LastName>Lozano</LastName><ForeName>Andres</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Nutt</LastName><ForeName>John G</ForeName><Initials>JG</Initials></Author><Author ValidYN="Y"><LastName>Penn</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Brooks</LastName><ForeName>David J</ForeName><Initials>DJ</Initials></Author><Author ValidYN="Y"><LastName>Hotton</LastName><ForeName>Gary</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Moro</LastName><ForeName>Elena</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Heywood</LastName><ForeName>Peter</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Brodsky</LastName><ForeName>Matthew A</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Burchiel</LastName><ForeName>Kim</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Kelly</LastName><ForeName>Patrick</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Dalvi</LastName><ForeName>Arif</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Scott</LastName><ForeName>Burton</ForeName><Initials>B</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>Wooten</LastName><ForeName>V G Frederich</ForeName><Initials>VG</Initials></Author><Author ValidYN="Y"><LastName>Elias</LastName><ForeName>William J</ForeName><Initials>WJ</Initials></Author><Author ValidYN="Y"><LastName>Laws</LastName><ForeName>Edward R</ForeName><Initials>ER</Initials></Author><Author ValidYN="Y"><LastName>Dhawan</LastName><ForeName>Vijay</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Stoessl</LastName><ForeName>A Jon</ForeName><Initials>AJ</Initials></Author><Author ValidYN="Y"><LastName>Matcham</LastName><ForeName>James</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Coffey</LastName><ForeName>Robert J</ForeName><Initials>RJ</Initials></Author><Author ValidYN="Y"><LastName>Traub</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>MC_U120036861</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><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>Ann Neurol</MedlineTA><NlmUniqueID>7707449</NlmUniqueID><ISSNLinking>0364-5134</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D051100">Glial Cell Line-Derived Neurotrophic Factor</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011994">Recombinant Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>63-84-3</RegistryNumber><NameOfSubstance UI="D004295">Dihydroxyphenylalanine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Ann Neurol. 2006 Mar;59(3):444-7</RefSource><PMID Version="1">16489617</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Ann Neurol. 2006 Mar;59(3):A5-6</RefSource><PMID Version="1">16489612</PMID></CommentsCorrections><CommentsCorrections RefType="ErratumIn"><RefSource>Ann Neurol. 2006 Dec;60(6):747</RefSource></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000704" MajorTopicYN="N">Analysis of Variance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004295" MajorTopicYN="N">Dihydroxyphenylalanine</DescriptorName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016503" MajorTopicYN="N">Drug Delivery Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004341" MajorTopicYN="N">Drug Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D051100" MajorTopicYN="N">Glial Cell Line-Derived Neurotrophic Factor</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></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="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D049268" MajorTopicYN="N">Positron-Emission Tomography</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011699" MajorTopicYN="N">Putamen</DescriptorName><QualifierName UI="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011994" MajorTopicYN="N">Recombinant Proteins</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2006</Year><Month>1</Month><Day>24</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2006</Year><Month>5</Month><Day>10</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2006</Year><Month>1</Month><Day>24</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">16429411</ArticleId><ArticleId IdType="doi">10.1002/ana.20737</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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