Randomized controlled trial of intraputamenal glial cell line–derived neurotrophic factor infusion in Parkinson disease
Identifieur interne : 001214 ( Main/Exploration ); précédent : 001213; suivant : 001215Randomized controlled trial of intraputamenal glial cell line–derived neurotrophic factor infusion in Parkinson disease
Auteurs : Anthony E. Lang [Canada] ; Steven Gill [Royaume-Uni] ; Nik K. Patel [Royaume-Uni] ; Andres Lozano [Canada] ; John G. Nutt [États-Unis] ; Richard Penn [États-Unis] ; David J. Brooks [Royaume-Uni] ; Gary Hotton [Royaume-Uni] ; Elena Moro [Canada] ; Peter Heywood [Canada] ; Matthew A. Brodsky [États-Unis] ; Kim Burchiel [États-Unis] ; Patrick Kelly [États-Unis] ; Arif Dalvi [États-Unis] ; Burton Scott [États-Unis] ; Mark Stacy [États-Unis] ; Dennis Turner [États-Unis] ; V. G. Frederich Wooten [États-Unis] ; William J. Elias [États-Unis] ; Edward R. Laws [États-Unis] ; Vijay Dhawan [États-Unis] ; A. Jon Stoessl [Canada] ; James Matcham [Royaume-Uni] ; Robert J. Coffey [États-Unis] ; Michael Traub [États-Unis]Source :
- Annals of Neurology [ 0364-5134 ] ; 2006-03.
Abstract
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). Methods: Thirty‐four PD patients were randomized 1 to 1 to receive bilateral continuous Ipu infusion of liatermin 15μg/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 18F‐dopa uptake. 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 18F‐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). Interpretation: Liatermin did not confer the predetermined level of clinical benefit to patients with PD despite increased 18F‐dopa uptake. It is uncertain whether technical differences between this trial and positive open‐label studies contributed in any way this negative outcome. Ann Neurol 2006
Url:
DOI: 10.1002/ana.20737
Affiliations:
- Canada, Royaume-Uni, États-Unis
- Angleterre, Californie, Caroline du Nord, Grand Londres, Illinois, Minnesota, Ontario, Oregon, Virginie, État de New York
- Londres, Toronto
- Université de Toronto
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Lang</name><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Hospital and the University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Gill, Steven" sort="Gill, Steven" uniqKey="Gill S" first="Steven" last="Gill">Steven Gill</name><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Frenchay Hospital, Bristol</wicri:regionArea><wicri:noRegion>Bristol</wicri:noRegion></affiliation></author><author><name sortKey="Patel, Nik K" sort="Patel, Nik K" uniqKey="Patel N" first="Nik K." last="Patel">Nik K. Patel</name><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Frenchay Hospital, Bristol</wicri:regionArea><wicri:noRegion>Bristol</wicri:noRegion></affiliation></author><author><name sortKey="Lozano, Andres" sort="Lozano, Andres" uniqKey="Lozano A" first="Andres" last="Lozano">Andres Lozano</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Research Institute, Toronto</wicri:regionArea><wicri:noRegion>Toronto</wicri:noRegion></affiliation></author><author><name sortKey="Nutt, John G" sort="Nutt, John G" uniqKey="Nutt J" first="John G." last="Nutt">John G. Nutt</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oregon</region></placeName><wicri:cityArea>Oregon Health and Science University, Parkinson Center of Oregon, Portland</wicri:cityArea></affiliation></author><author><name sortKey="Penn, Richard" sort="Penn, Richard" uniqKey="Penn R" first="Richard" last="Penn">Richard Penn</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>University of Chicago, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Brooks, David J" sort="Brooks, David J" uniqKey="Brooks D" first="David J." last="Brooks">David J. Brooks</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Imperial College, Hammersmith Hospital, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Hotton, Gary" sort="Hotton, Gary" uniqKey="Hotton G" first="Gary" last="Hotton">Gary Hotton</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Imperial College, Hammersmith Hospital, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Moro, Elena" sort="Moro, Elena" uniqKey="Moro E" first="Elena" last="Moro">Elena Moro</name><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Hospital and the University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Heywood, Peter" sort="Heywood, Peter" uniqKey="Heywood P" first="Peter" last="Heywood">Peter Heywood</name><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Hospital and the University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Brodsky, Matthew A" sort="Brodsky, Matthew A" uniqKey="Brodsky M" first="Matthew A." last="Brodsky">Matthew A. Brodsky</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oregon</region></placeName><wicri:cityArea>Oregon Health and Science University, Parkinson Center of Oregon, Portland</wicri:cityArea></affiliation></author><author><name sortKey="Burchiel, Kim" sort="Burchiel, Kim" uniqKey="Burchiel K" first="Kim" last="Burchiel">Kim Burchiel</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Oregon</region></placeName><wicri:cityArea>Oregon Health and Science University, Parkinson Center of Oregon, Portland</wicri:cityArea></affiliation></author><author><name sortKey="Kelly, Patrick" sort="Kelly, Patrick" uniqKey="Kelly P" first="Patrick" last="Kelly">Patrick Kelly</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>New York University Medical Center, New York</wicri:cityArea></affiliation></author><author><name sortKey="Dalvi, Arif" sort="Dalvi, Arif" uniqKey="Dalvi A" first="Arif" last="Dalvi">Arif Dalvi</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>University of Chicago, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Scott, Burton" sort="Scott, Burton" uniqKey="Scott B" first="Burton" last="Scott">Burton Scott</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Duke Movement Disorders Clinic, Durham</wicri:cityArea></affiliation></author><author><name sortKey="Stacy, Mark" sort="Stacy, Mark" uniqKey="Stacy M" first="Mark" last="Stacy">Mark Stacy</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Duke University, Durham</wicri:cityArea></affiliation></author><author><name sortKey="Turner, Dennis" sort="Turner, Dennis" uniqKey="Turner D" first="Dennis" last="Turner">Dennis Turner</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Duke University, Durham</wicri:cityArea></affiliation></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><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>University of Virginia, Charlottesville</wicri:cityArea></affiliation></author><author><name sortKey="Elias, William J" sort="Elias, William J" uniqKey="Elias W" first="William J." last="Elias">William J. Elias</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>University of Virginia, Charlottesville</wicri:cityArea></affiliation></author><author><name sortKey="Laws, Edward R" sort="Laws, Edward R" uniqKey="Laws E" first="Edward R." last="Laws">Edward R. Laws</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>University of Virginia, Charlottesville</wicri:cityArea></affiliation></author><author><name sortKey="Dhawan, Vijay" sort="Dhawan, Vijay" uniqKey="Dhawan V" first="Vijay" last="Dhawan">Vijay Dhawan</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>North Shore Long Island Jewish Research Institute, Manhasset</wicri:cityArea></affiliation></author><author><name sortKey="Stoessl, A Jon" sort="Stoessl, A Jon" uniqKey="Stoessl A" first="A. Jon" last="Stoessl">A. Jon Stoessl</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>University of British Columbia, Vancouver, British Columbia</wicri:regionArea><wicri:noRegion>British Columbia</wicri:noRegion></affiliation></author><author><name sortKey="Matcham, James" sort="Matcham, James" uniqKey="Matcham J" first="James" last="Matcham">James Matcham</name><affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Amgen Ltd., Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Coffey, Robert J" sort="Coffey, Robert J" uniqKey="Coffey R" first="Robert J." last="Coffey">Robert J. Coffey</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Minnesota</region></placeName><wicri:cityArea>Medtronic Inc., Minneapolis</wicri:cityArea></affiliation></author><author><name sortKey="Traub, Michael" sort="Traub, Michael" uniqKey="Traub M" first="Michael" last="Traub">Michael Traub</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen Inc., Thousand Oaks</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Neurology</title><title level="j" type="abbrev">Ann Neurol.</title><idno type="ISSN">0364-5134</idno><idno type="eISSN">1531-8249</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2006-03">2006-03</date><biblScope unit="volume">59</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="459">459</biblScope><biblScope unit="page" to="466">466</biblScope></imprint><idno type="ISSN">0364-5134</idno></series><idno type="istex">6CFE15E0209DCA843C277139795F853D5A1C135C</idno><idno type="DOI">10.1002/ana.20737</idno><idno type="ArticleID">ANA20737</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0364-5134</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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). Methods: Thirty‐four PD patients were randomized 1 to 1 to receive bilateral continuous Ipu infusion of liatermin 15μg/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 18F‐dopa uptake. 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 18F‐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). Interpretation: Liatermin did not confer the predetermined level of clinical benefit to patients with PD despite increased 18F‐dopa uptake. It is uncertain whether technical differences between this trial and positive open‐label studies contributed in any way this negative outcome. Ann Neurol 2006</div></front></TEI><affiliations><list><country><li>Canada</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>Caroline du Nord</li><li>Grand Londres</li><li>Illinois</li><li>Minnesota</li><li>Ontario</li><li>Oregon</li><li>Virginie</li><li>État de New York</li></region><settlement><li>Londres</li><li>Toronto</li></settlement><orgName><li>Université de Toronto</li></orgName></list><tree><country name="Canada"><region name="Ontario"><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name></region><name sortKey="Heywood, Peter" sort="Heywood, Peter" uniqKey="Heywood P" first="Peter" last="Heywood">Peter Heywood</name><name sortKey="Lozano, Andres" sort="Lozano, Andres" uniqKey="Lozano A" first="Andres" last="Lozano">Andres Lozano</name><name sortKey="Moro, Elena" sort="Moro, Elena" uniqKey="Moro E" first="Elena" last="Moro">Elena Moro</name><name sortKey="Stoessl, A Jon" sort="Stoessl, A Jon" uniqKey="Stoessl A" first="A. Jon" last="Stoessl">A. Jon Stoessl</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Gill, Steven" sort="Gill, Steven" uniqKey="Gill S" first="Steven" last="Gill">Steven Gill</name></noRegion><name sortKey="Brooks, David J" sort="Brooks, David J" uniqKey="Brooks D" first="David J." last="Brooks">David J. Brooks</name><name sortKey="Hotton, Gary" sort="Hotton, Gary" uniqKey="Hotton G" first="Gary" last="Hotton">Gary Hotton</name><name sortKey="Matcham, James" sort="Matcham, James" uniqKey="Matcham J" first="James" last="Matcham">James Matcham</name><name sortKey="Patel, Nik K" sort="Patel, Nik K" uniqKey="Patel N" first="Nik K." last="Patel">Nik K. Patel</name></country><country name="États-Unis"><region name="Oregon"><name sortKey="Nutt, John G" sort="Nutt, John G" uniqKey="Nutt J" first="John G." last="Nutt">John G. Nutt</name></region><name sortKey="Brodsky, Matthew A" sort="Brodsky, Matthew A" uniqKey="Brodsky M" first="Matthew A." last="Brodsky">Matthew A. Brodsky</name><name sortKey="Burchiel, Kim" sort="Burchiel, Kim" uniqKey="Burchiel K" first="Kim" last="Burchiel">Kim Burchiel</name><name sortKey="Coffey, Robert J" sort="Coffey, Robert J" uniqKey="Coffey R" first="Robert J." last="Coffey">Robert J. Coffey</name><name sortKey="Dalvi, Arif" sort="Dalvi, Arif" uniqKey="Dalvi A" first="Arif" last="Dalvi">Arif Dalvi</name><name sortKey="Dhawan, Vijay" sort="Dhawan, Vijay" uniqKey="Dhawan V" first="Vijay" last="Dhawan">Vijay Dhawan</name><name sortKey="Elias, William J" sort="Elias, William J" uniqKey="Elias W" first="William J." last="Elias">William J. Elias</name><name sortKey="Kelly, Patrick" sort="Kelly, Patrick" uniqKey="Kelly P" first="Patrick" last="Kelly">Patrick Kelly</name><name sortKey="Laws, Edward R" sort="Laws, Edward R" uniqKey="Laws E" first="Edward R." last="Laws">Edward R. Laws</name><name sortKey="Penn, Richard" sort="Penn, Richard" uniqKey="Penn R" first="Richard" last="Penn">Richard Penn</name><name sortKey="Scott, Burton" sort="Scott, Burton" uniqKey="Scott B" first="Burton" last="Scott">Burton Scott</name><name sortKey="Stacy, Mark" sort="Stacy, Mark" uniqKey="Stacy M" first="Mark" last="Stacy">Mark Stacy</name><name sortKey="Traub, Michael" sort="Traub, Michael" uniqKey="Traub M" first="Michael" last="Traub">Michael Traub</name><name sortKey="Turner, Dennis" sort="Turner, Dennis" uniqKey="Turner D" first="Dennis" last="Turner">Dennis Turner</name><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></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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