Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson'd Disease: Final 12-Month, Open-Label Results
Identifieur interne : 001A17 ( Ncbi/Merge ); précédent : 001A16; suivant : 001A18Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson'd Disease: Final 12-Month, Open-Label Results
Auteurs : Hubert H. Fernandez [États-Unis] ; David G. Standaert [États-Unis] ; Robert A. Hauser [États-Unis] ; Anthony E. Lang [Canada] ; Victor Sc Fung [Australie] ; Fabian Klostermann [Allemagne] ; Mark F. Lew [États-Unis] ; Per Odin [Suède] ; Malcolm Steiger [Royaume-Uni] ; Eduard Z. Yakupov [Russie] ; Sylvain Chouinard [Canada] ; Oksana Suchowersky [Canada] ; Jordan Dubow [États-Unis] ; Coleen M. Hall [États-Unis] ; Krai Chatamra [États-Unis] ; Weining Z. Robieson [États-Unis] ; Janet A. Benesh [États-Unis] ; Alberto J. Espay [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2014.
Abstract
Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation.
Url:
DOI: 10.1002/mds.26123
PubMed: 25545465
PubMed Central: 4674978
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Fernandez</name><affiliation wicri:level="2"><nlm:aff id="au1"><institution>Center for Neurological Restoration, Cleveland Clinic</institution><addr-line>Cleveland, Ohio, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cleveland, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Standaert, David G" sort="Standaert, David G" uniqKey="Standaert D" first="David G" last="Standaert">David G. Standaert</name><affiliation wicri:level="2"><nlm:aff id="au2"><institution>University of Alabama at Birmingham</institution><addr-line>Birmingham, Alabama, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Birmingham, Alabama</wicri:regionArea><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="2"><nlm:aff id="au3"><institution>Department of Neurology, University of South Florida</institution><addr-line>Tampa, Florida, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Tampa, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name><affiliation wicri:level="1"><nlm:aff id="au4"><institution>University of Toronto</institution><addr-line>Toronto, Ontario, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Fung, Victor Sc" sort="Fung, Victor Sc" uniqKey="Fung V" first="Victor Sc" last="Fung">Victor Sc Fung</name><affiliation wicri:level="1"><nlm:aff id="au5"><institution>Movement Disorders Unit, Westmead Hospital and Sydney Medical School</institution><addr-line>Sydney, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name><affiliation wicri:level="1"><nlm:aff id="au6"><institution>Charité-University Medicine Berlin</institution><addr-line>Berlin, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name><affiliation wicri:level="2"><nlm:aff id="au7"><institution>Keck/USC School of Medicine</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Los Angeles, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name><affiliation wicri:level="1"><nlm:aff id="au8"><institution>Klinikum-Bremerhaven, Bremerhaven, Germany and Skane University Hospital</institution><addr-line>Lund, Sweden</addr-line></nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Lund</wicri:regionArea></affiliation></author><author><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name><affiliation wicri:level="1"><nlm:aff id="au9"><institution>Walton Center for Neurology and Neurosurgery</institution><addr-line>Liverpool, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liverpool</wicri:regionArea></affiliation></author><author><name sortKey="Yakupov, Eduard Z" sort="Yakupov, Eduard Z" uniqKey="Yakupov E" first="Eduard Z" last="Yakupov">Eduard Z. Yakupov</name><affiliation wicri:level="1"><nlm:aff id="au10"><institution>Kazan State Medical University</institution><addr-line>Kazan, Russia</addr-line></nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>Kazan</wicri:regionArea></affiliation></author><author><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name><affiliation wicri:level="1"><nlm:aff id="au11"><institution>University of Montreal</institution><addr-line>Montreal, Quebec, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Montreal, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation></author><author><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name><affiliation wicri:level="1"><nlm:aff id="au12"><institution>University of Alberta</institution><addr-line>Edmonton, Alberta, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Edmonton, Alberta</wicri:regionArea><wicri:noRegion>Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Hall, Coleen M" sort="Hall, Coleen M" uniqKey="Hall C" first="Coleen M" last="Hall">Coleen M. Hall</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z" last="Robieson">Weining Z. Robieson</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Benesh, Janet A" sort="Benesh, Janet A" uniqKey="Benesh J" first="Janet A" last="Benesh">Janet A. Benesh</name><affiliation wicri:level="1"><nlm:aff id="au13"><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name><affiliation wicri:level="2"><nlm:aff id="au14"><institution>University of Cincinnati Academic Health Center</institution><addr-line>Cincinnati, Ohio, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cincinnati, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author></analytic><series><title level="j">Movement Disorders</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. <sc>l</sc>-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces <sc>l-</sc>dopa-plasma–level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day “off” time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, “on” time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (<italic>P</italic> < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (<italic>P</italic> < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (<italic>P</italic> = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, <sc>l-</sc>dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks. © 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Hauser, Ra" uniqKey="Hauser R">RA Hauser</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hornykiewicz, O" uniqKey="Hornykiewicz O">O Hornykiewicz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lundqvist, C" uniqKey="Lundqvist C">C Lundqvist</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Antonini, A" uniqKey="Antonini A">A Antonini</name></author><author><name sortKey="Chaudhuri, Kr" uniqKey="Chaudhuri K">KR Chaudhuri</name></author><author><name sortKey="Martinez Martin, P" uniqKey="Martinez Martin P">P Martinez-Martin</name></author><author><name sortKey="Odin, P" uniqKey="Odin P">P 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article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Mov Disord</journal-id><journal-id journal-id-type="iso-abbrev">Mov. Disord</journal-id><journal-id journal-id-type="publisher-id">mds</journal-id><journal-title-group><journal-title>Movement Disorders</journal-title></journal-title-group><issn pub-type="ppub">0885-3185</issn><issn pub-type="epub">1531-8257</issn><publisher><publisher-name>Blackwell Publishing Ltd</publisher-name><publisher-loc>Oxford, UK</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25545465</article-id><article-id pub-id-type="pmc">4674978</article-id><article-id pub-id-type="doi">10.1002/mds.26123</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Articles</subject></subj-group></article-categories><title-group><article-title>Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson'd Disease: Final 12-Month, Open-Label Results</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Fernandez</surname><given-names>Hubert H</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="au1">1</xref><xref ref-type="corresp" rid="cor1">*</xref></contrib><contrib contrib-type="author"><name><surname>Standaert</surname><given-names>David G</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="au2">2</xref></contrib><contrib contrib-type="author"><name><surname>Hauser</surname><given-names>Robert A</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Lang</surname><given-names>Anthony E</given-names></name><degrees>MD, FRCPC</degrees><xref ref-type="aff" rid="au4">4</xref></contrib><contrib contrib-type="author"><name><surname>Fung</surname><given-names>Victor SC</given-names></name><degrees>PhD, FRACP</degrees><xref ref-type="aff" rid="au5">5</xref></contrib><contrib contrib-type="author"><name><surname>Klostermann</surname><given-names>Fabian</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="au6">6</xref></contrib><contrib contrib-type="author"><name><surname>Lew</surname><given-names>Mark F</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="au7">7</xref></contrib><contrib contrib-type="author"><name><surname>Odin</surname><given-names>Per</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="au8">8</xref></contrib><contrib contrib-type="author"><name><surname>Steiger</surname><given-names>Malcolm</given-names></name><degrees>MBBS, MD, FRCP</degrees><xref ref-type="aff" rid="au9">9</xref></contrib><contrib contrib-type="author"><name><surname>Yakupov</surname><given-names>Eduard Z</given-names></name><degrees>MD, PhD, DMSc</degrees><xref ref-type="aff" rid="au10">10</xref></contrib><contrib contrib-type="author"><name><surname>Chouinard</surname><given-names>Sylvain</given-names></name><degrees>MD, FRCPC</degrees><xref ref-type="aff" rid="au11">11</xref></contrib><contrib contrib-type="author"><name><surname>Suchowersky</surname><given-names>Oksana</given-names></name><degrees>MD, FRCPC, FCCMG</degrees><xref ref-type="aff" rid="au12">12</xref></contrib><contrib contrib-type="author"><name><surname>Dubow</surname><given-names>Jordan</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="au13">13</xref></contrib><contrib contrib-type="author"><name><surname>Hall</surname><given-names>Coleen M</given-names></name><degrees>MS</degrees><xref ref-type="aff" rid="au13">13</xref></contrib><contrib contrib-type="author"><name><surname>Chatamra</surname><given-names>Krai</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="au13">13</xref></contrib><contrib contrib-type="author"><name><surname>Robieson</surname><given-names>Weining Z</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="au13">13</xref></contrib><contrib contrib-type="author"><name><surname>Benesh</surname><given-names>Janet A</given-names></name><degrees>BSMT</degrees><xref ref-type="aff" rid="au13">13</xref></contrib><contrib contrib-type="author"><name><surname>Espay</surname><given-names>Alberto J</given-names></name><degrees>MD, MSc</degrees><xref ref-type="aff" rid="au14">14</xref></contrib><aff id="au1"><label>1</label><institution>Center for Neurological Restoration, Cleveland Clinic</institution><addr-line>Cleveland, Ohio, USA</addr-line></aff><aff id="au2"><label>2</label><institution>University of Alabama at Birmingham</institution><addr-line>Birmingham, Alabama, USA</addr-line></aff><aff id="au3"><label>3</label><institution>Department of Neurology, University of South Florida</institution><addr-line>Tampa, Florida, USA</addr-line></aff><aff id="au4"><label>4</label><institution>University of Toronto</institution><addr-line>Toronto, Ontario, Canada</addr-line></aff><aff id="au5"><label>5</label><institution>Movement Disorders Unit, Westmead Hospital and Sydney Medical School</institution><addr-line>Sydney, Australia</addr-line></aff><aff id="au6"><label>6</label><institution>Charité-University Medicine Berlin</institution><addr-line>Berlin, Germany</addr-line></aff><aff id="au7"><label>7</label><institution>Keck/USC School of Medicine</institution><addr-line>Los Angeles, California, USA</addr-line></aff><aff id="au8"><label>8</label><institution>Klinikum-Bremerhaven, Bremerhaven, Germany and Skane University Hospital</institution><addr-line>Lund, Sweden</addr-line></aff><aff id="au9"><label>9</label><institution>Walton Center for Neurology and Neurosurgery</institution><addr-line>Liverpool, United Kingdom</addr-line></aff><aff id="au10"><label>10</label><institution>Kazan State Medical University</institution><addr-line>Kazan, Russia</addr-line></aff><aff id="au11"><label>11</label><institution>University of Montreal</institution><addr-line>Montreal, Quebec, Canada</addr-line></aff><aff id="au12"><label>12</label><institution>University of Alberta</institution><addr-line>Edmonton, Alberta, Canada</addr-line></aff><aff id="au13"><label>13</label><institution>AbbVie Inc., North Chicago</institution><addr-line>Illinois, USA</addr-line></aff><aff id="au14"><label>14</label><institution>University of Cincinnati Academic Health Center</institution><addr-line>Cincinnati, Ohio, USA</addr-line></aff></contrib-group><author-notes><corresp id="cor1">*<bold>Correspondence to</bold>: Dr. Hubert H. Fernandez, Center for Neurological Restoration, Cleveland Clinic, 9500 Euclid Avenue, U-2, Cleveland, OH 44195, USA; <email>fernanh@ccf.org</email> or Dr. David G. Standaert, Department of Neurology, 1719 6th Avenue South, CIRC 516, Birmingham, AL 35294, USA; <email>dstandaert@uab.edu</email></corresp><fn><p><bold>Funding agencies:</bold> This study was sponsored by AbbVie Inc. (North Chicago, IL, USA), which participated in the study design, research, data collection, analysis and interpretation of data, writing, reviewing, and approving the publication. Funding for editorial and graphic support was provided by AbbVie Inc. to The Curry Rockefeller Group, LLC; medical writing assistance was provided by Michael Feirtag, Susan Kralian, PhD, Paul V. Shea, Jennifer Kuo, PharmD, and John Norwood of The Curry Rockefeller Group, LLC.</p></fn><fn><p><bold>Relevant conflicts of interest/financial disclosures:</bold> H.H.F. was a study investigator and has served as a consultant for AbbVie Inc. through a contract between AbbVie Inc. and Cleveland Clinic Foundation; he has not received any personal compensation from AbbVie Inc. D.G.S. was a study investigator for, and has received compensation from, AbbVie Inc. for serving as a consultant and/or participating in scientific advisory boards. R.A.H. was a study investigator for AbbVie Inc. and has received honoraria or payments for consulting, advisory services, or speaking services over the past 12 months from AbbVie Inc. A.E.L. was a study investigator for AbbVie Inc. and has received compensation from AbbVie Inc. for participating in scientific advisory boards. V.S.C.F. was a study investigator for, and has also received compensation from, AbbVie Inc. for participating in scientific advisory boards; AbbVie Inc. contributed to funding for a Parkinson's disease nurse specialist in the form of a grant to his institution. F.K. was a study investigator for, and has received compensation from, AbbVie Inc. for participating in scientific advisory boards and for serving as a lecturer. M.F.L. was a study investigator for AbbVie Inc. P.O. was a study investigator in AbbVie Inc.-sponsored studies and has received compensation from AbbVie Inc. for serving as a consultant and lecturer. M.S. was a study investigator in AbbVie Inc.-sponsored studies and has received compensation from AbbVie Inc. for participating in scientific advisory boards. E.Z.Y. was a study investigator for, and has received compensation from, AbbVie Inc. for serving as a lecturer. S.C. was a study investigator for, and has received compensation from, AbbVie Inc. for serving as a consultant, lecturer, and/or participating in scientific advisory boards. O.S. was a study investigator for, and has received compensation from, AbbVie Inc. for serving as a consultant and/or participating in scientific advisory boards. J.D., C.M.H., K.C., W.Z.R., and J.A.B. are employees of AbbVie Inc. A.J.E. was a study investigator for, and has received compensation from, AbbVie Inc. for serving as a consultant, lecturer, and/or participating in scientific advisory boards.</p></fn><fn><p>Full financial disclosures and author roles may be found in the online version of this article.</p></fn></author-notes><pub-date pub-type="ppub"><month>4</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>24</day><month>12</month><year>2014</year></pub-date><volume>30</volume><issue>4</issue><fpage>500</fpage><lpage>509</lpage><history><date date-type="received"><day>28</day><month>8</month><year>2014</year></date><date date-type="rev-recd"><day>07</day><month>11</month><year>2014</year></date><date date-type="accepted"><day>18</day><month>11</month><year>2014</year></date></history><permissions><copyright-statement>© 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</copyright-statement><copyright-year>2014</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.</license-p></license></permissions><abstract><p>Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. <sc>l</sc>-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces <sc>l-</sc>dopa-plasma–level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day “off” time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, “on” time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (<italic>P</italic> < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (<italic>P</italic> < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (<italic>P</italic> = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, <sc>l-</sc>dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks. © 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</p></abstract><kwd-group><kwd>dyskinesia</kwd><kwd>infusion</kwd><kwd>levodopa-carbidopa intestinal gel</kwd><kwd>“off” time</kwd><kwd>percutaneous endoscopic gastrojejunostomy</kwd></kwd-group></article-meta></front></pmc><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Royaume-Uni</li><li>Russie</li><li>Suède</li><li>États-Unis</li></country><region><li>Alabama</li><li>Californie</li><li>Floride</li><li>Ohio</li></region></list><tree><country name="États-Unis"><region name="Ohio"><name sortKey="Fernandez, Hubert H" sort="Fernandez, Hubert H" uniqKey="Fernandez H" first="Hubert H" last="Fernandez">Hubert H. Fernandez</name></region><name sortKey="Benesh, Janet A" sort="Benesh, Janet A" uniqKey="Benesh J" first="Janet A" last="Benesh">Janet A. Benesh</name><name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name><name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name><name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name><name sortKey="Hall, Coleen M" sort="Hall, Coleen M" uniqKey="Hall C" first="Coleen M" last="Hall">Coleen M. Hall</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name><name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z" last="Robieson">Weining Z. Robieson</name><name sortKey="Standaert, David G" sort="Standaert, David G" uniqKey="Standaert D" first="David G" last="Standaert">David G. Standaert</name></country><country name="Canada"><noRegion><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name></noRegion><name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></country><country name="Australie"><noRegion><name sortKey="Fung, Victor Sc" sort="Fung, Victor Sc" uniqKey="Fung V" first="Victor Sc" last="Fung">Victor Sc Fung</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name></noRegion></country><country name="Suède"><noRegion><name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name></noRegion></country><country name="Russie"><noRegion><name sortKey="Yakupov, Eduard Z" sort="Yakupov, Eduard Z" uniqKey="Yakupov E" first="Eduard Z" last="Yakupov">Eduard Z. 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