Safety and Efficacy of Perampanel in Advanced Parkinson's Disease: A Randomized, Placebo-Controlled Study
Identifieur interne : 000849 ( PascalFrancis/Checkpoint ); précédent : 000848; suivant : 000850Safety and Efficacy of Perampanel in Advanced Parkinson's Disease: A Randomized, Placebo-Controlled Study
Auteurs : Karla Eggert [Allemagne] ; David Squillacote [États-Unis] ; Paolo Barone [Italie] ; Richard Dodel [Allemagne] ; Regina Katzenschlager [Autriche] ; Murat Emre [Turquie] ; Andrew Lees (neurologue) [Royaume-Uni] ; Olivier Rascol [France] ; Werner Poewe [Autriche] ; Eduardo Tolosa [Espagne] ; Claudia Trenkwalder [Allemagne] ; Marco Onofrj [Italie] ; Fabrizio Stocchi [Italie] ; Giuseppe Nappi [Italie] ; Vladimir Kostic [Serbie] ; Jagoda Potic [Serbie] ; Evzen Ruzicka [République tchèque] ; Wolfgang Oertel [Allemagne]Source :
- Movement disorders [ 0885-3185 ] ; 2010.
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- Pascal (Inist)
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Abstract
Perampanel, a novel, noncompetitive, selective AMPA-receptor antagonist demonstrated evidence of efficacy in reducing motor symptoms in animal models of Parkinson's disease (PD). We assessed the safety and efficacy of perampanel for treatment of "wearing off" motor fluctuations in patients with PD. Patients (N = 263) were randomly assigned to once-daily add-on 0.5, 1, or 2 mg of perampanel or placebo. The primary objective was to determine whether there was a dose-response relationship for efficacy among the 3 perampanel doses and placebo. The primary efficacy endpoint for each treatment was measured as the least-squares (LS) mean change from baseline to week 12 in percent "off' time reduction during the waking day, as recorded by patient diaries. The primary efficacy analysis was a 1-sided Williams test for dose-response trend at the 0.025 level of significance. At week 12, dose-response trends, as determined by the Williams test, were not statistically significant for LS mean reduction in percent "off" time during the waking day (P = 0.061, with significance defined as P ≤ 0.025). The 2 higher perampanel doses (ITT population; n = 258) produced non-significant reductions from baseline to week 12 in percent "off" time during the waking day versus placebo (7.59%, P = 0.421 [1 mg], 8.60%, P = 0.257 [2 mg] versus 5.05% [placebo]; significance for pairwise comparisons defined as P ≤ 0.05). There were no significant changes in dyskinesia or cognitive function in any perampanel group versus placebo. Adverse events were similar across treatment groups. Perampanel treatment was well tolerated and safe, but failed to achieve statistical significance in primary and secondary endpoints.
Affiliations:
- Allemagne, Autriche, Espagne, France, Italie, Royaume-Uni, République tchèque, Serbie, Turquie, États-Unis
- Angleterre, Bohême centrale, Catalogne, District de Cologne, District de Giessen, District de Kassel, Grand Londres, Hesse (Land), Latium, Midi-Pyrénées, New Jersey, Rhénanie-du-Nord-Westphalie, Tyrol (Land), Vienne (Autriche)
- Barcelone, Bonn, Cassel (Hesse), Innsbruck, Londres, Marbourg, Prague, Rome, Toulouse, Vienne (Autriche)
- National Hospital for Neurology and Neurosurgery, Université Toulouse III - Paul Sabatier, Université de Toulouse, Université de médecine d'Innsbruck
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Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>8 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Neurology, Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>9 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>10 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Paracelsus-Elena Klinik</s1><s2>Kassel</s2><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Kassel</region><settlement type="city">Cassel (Hesse)</settlement></placeName></affiliation></author><author><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Clinica Neurologica, Università Chieti-Pescara</s1><s3>ITA</s3><sZ>12 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Clinica Neurologica, Università Chieti-Pescara</wicri:noRegion></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Department of Neurology, IRCCS San Raffaele</s1><s2>Rome</s2><s3>ITA</s3><sZ>13 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Nappi, Giuseppe" sort="Nappi, Giuseppe" uniqKey="Nappi G" first="Giuseppe" last="Nappi">Giuseppe Nappi</name><affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Chair of Neurology, University "La Sapienza</s1><s2>Rome</s2><s3>ITA</s3><sZ>14 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>14 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>IRCCS "C. Mondino Institute of Neurology" Foundation</wicri:noRegion></affiliation></author><author><name sortKey="Kostic, Vladimir" sort="Kostic, Vladimir" uniqKey="Kostic V" first="Vladimir" last="Kostic">Vladimir Kostic</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Institute of Neurology, Clinical Centre of Serbia</s1><s2>Belgrade</s2><s3>SRB</s3><sZ>15 aut.</sZ></inist:fA14><country>Serbie</country><wicri:noRegion>Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Potic, Jagoda" sort="Potic, Jagoda" uniqKey="Potic J" first="Jagoda" last="Potic">Jagoda Potic</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara</s1><s2>Belgrade</s2><s3>SRB</s3><sZ>16 aut.</sZ></inist:fA14><country>Serbie</country><wicri:noRegion>Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Ruzicka, Evzen" sort="Ruzicka, Evzen" uniqKey="Ruzicka E" first="Evzen" last="Ruzicka">Evzen Ruzicka</name><affiliation wicri:level="3"><inist:fA14 i1="19"><s1>Department of Neurology, Charles University in Prague, 1st Faculty of Medicine and General Teaching Hospital</s1><s2>Prague</s2><s3>CZE</s3><sZ>17 aut.</sZ></inist:fA14><country>République tchèque</country><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps-University Marburg</s1><s2>Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0288342</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 10-0288342 INIST</idno><idno type="RBID">Pascal:10-0288342</idno><idno type="wicri:Area/PascalFrancis/Corpus">000B14</idno><idno type="wicri:Area/PascalFrancis/Curation">002205</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000849</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Safety and Efficacy of Perampanel in Advanced Parkinson's Disease: A Randomized, Placebo-Controlled Study</title><author><name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps-University Marburg</s1><s2>Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Squillacote, David" sort="Squillacote, David" uniqKey="Squillacote D" first="David" last="Squillacote">David Squillacote</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake</s1><s2>New Jersey</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Neurological Sciences, University of Naples Federico II-IDC Hermitage-Capodimonte</s1><s2>Naples</s2><s3>ITA</s3><sZ>3 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Naples</wicri:noRegion></affiliation></author><author><name sortKey="Dodel, Richard" sort="Dodel, Richard" uniqKey="Dodel R" first="Richard" last="Dodel">Richard Dodel</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Neurology, Rheinische Friedrich-Wilhelms-University</s1><s2>Bonn</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Cologne</region><settlement type="city">Bonn</settlement></placeName></affiliation></author><author><name sortKey="Katzenschlager, Regina" sort="Katzenschlager, Regina" uniqKey="Katzenschlager R" first="Regina" last="Katzenschlager">Regina Katzenschlager</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Neurology, Donauspital</s1><s2>Vienna</s2><s3>AUT</s3><sZ>5 aut.</sZ></inist:fA14><country>Autriche</country><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, Istanbul Medical School</s1><s2>Istanbul</s2><s3>TUR</s3><sZ>6 aut.</sZ></inist:fA14><country>Turquie</country><wicri:noRegion>Istanbul</wicri:noRegion></affiliation></author><author><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew Lees (neurologue)</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Reta Lila Weston Institute of Neurological Studies, University College London</s1><s2>London</s2><s3>GBR</s3><sZ>7 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName>National Hospital for Neurology and Neurosurgery</orgName></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>8 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>8 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Neurology, Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>9 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>10 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Paracelsus-Elena Klinik</s1><s2>Kassel</s2><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Kassel</region><settlement type="city">Cassel (Hesse)</settlement></placeName></affiliation></author><author><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Clinica Neurologica, Università Chieti-Pescara</s1><s3>ITA</s3><sZ>12 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Clinica Neurologica, Università Chieti-Pescara</wicri:noRegion></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Department of Neurology, IRCCS San Raffaele</s1><s2>Rome</s2><s3>ITA</s3><sZ>13 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Nappi, Giuseppe" sort="Nappi, Giuseppe" uniqKey="Nappi G" first="Giuseppe" last="Nappi">Giuseppe Nappi</name><affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Chair of Neurology, University "La Sapienza</s1><s2>Rome</s2><s3>ITA</s3><sZ>14 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>14 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>IRCCS "C. Mondino Institute of Neurology" Foundation</wicri:noRegion></affiliation></author><author><name sortKey="Kostic, Vladimir" sort="Kostic, Vladimir" uniqKey="Kostic V" first="Vladimir" last="Kostic">Vladimir Kostic</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Institute of Neurology, Clinical Centre of Serbia</s1><s2>Belgrade</s2><s3>SRB</s3><sZ>15 aut.</sZ></inist:fA14><country>Serbie</country><wicri:noRegion>Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Potic, Jagoda" sort="Potic, Jagoda" uniqKey="Potic J" first="Jagoda" last="Potic">Jagoda Potic</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara</s1><s2>Belgrade</s2><s3>SRB</s3><sZ>16 aut.</sZ></inist:fA14><country>Serbie</country><wicri:noRegion>Belgrade</wicri:noRegion></affiliation></author><author><name sortKey="Ruzicka, Evzen" sort="Ruzicka, Evzen" uniqKey="Ruzicka E" first="Evzen" last="Ruzicka">Evzen Ruzicka</name><affiliation wicri:level="3"><inist:fA14 i1="19"><s1>Department of Neurology, Charles University in Prague, 1st Faculty of Medicine and General Teaching Hospital</s1><s2>Prague</s2><s3>CZE</s3><sZ>17 aut.</sZ></inist:fA14><country>République tchèque</country><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps-University Marburg</s1><s2>Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AMPA receptor</term><term>Advanced stage</term><term>Dyskinesia</term><term>Fluctuations</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Perampanel</term><term>Placebo</term><term>Safety</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Dyskinésie</term><term>Pathologie du système nerveux</term><term>Sécurité</term><term>Pérampanel</term><term>Stade avancé</term><term>Placebo</term><term>Fluctuation</term><term>Récepteur AMPA</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Perampanel, a novel, noncompetitive, selective AMPA-receptor antagonist demonstrated evidence of efficacy in reducing motor symptoms in animal models of Parkinson's disease (PD). We assessed the safety and efficacy of perampanel for treatment of "wearing off" motor fluctuations in patients with PD. Patients (N = 263) were randomly assigned to once-daily add-on 0.5, 1, or 2 mg of perampanel or placebo. The primary objective was to determine whether there was a dose-response relationship for efficacy among the 3 perampanel doses and placebo. The primary efficacy endpoint for each treatment was measured as the least-squares (LS) mean change from baseline to week 12 in percent "off' time reduction during the waking day, as recorded by patient diaries. The primary efficacy analysis was a 1-sided Williams test for dose-response trend at the 0.025 level of significance. At week 12, dose-response trends, as determined by the Williams test, were not statistically significant for LS mean reduction in percent "off" time during the waking day (P = 0.061, with significance defined as P ≤ 0.025). The 2 higher perampanel doses (ITT population; n = 258) produced non-significant reductions from baseline to week 12 in percent "off" time during the waking day versus placebo (7.59%, P = 0.421 [1 mg], 8.60%, P = 0.257 [2 mg] versus 5.05% [placebo]; significance for pairwise comparisons defined as P ≤ 0.05). There were no significant changes in dyskinesia or cognitive function in any perampanel group versus placebo. Adverse events were similar across treatment groups. Perampanel treatment was well tolerated and safe, but failed to achieve statistical significance in primary and secondary endpoints.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0></fA01><fA03 i2="1"><s0>Mov. disord.</s0></fA03><fA05><s2>25</s2></fA05><fA06><s2>7</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Safety and Efficacy of Perampanel in Advanced Parkinson's Disease: A Randomized, Placebo-Controlled Study</s1></fA08><fA11 i1="01" i2="1"><s1>EGGERT (Karla)</s1></fA11><fA11 i1="02" i2="1"><s1>SQUILLACOTE (David)</s1></fA11><fA11 i1="03" i2="1"><s1>BARONE (Paolo)</s1></fA11><fA11 i1="04" i2="1"><s1>DODEL (Richard)</s1></fA11><fA11 i1="05" i2="1"><s1>KATZENSCHLAGER (Regina)</s1></fA11><fA11 i1="06" i2="1"><s1>EMRE (Murat)</s1></fA11><fA11 i1="07" i2="1"><s1>LEES (Andrew J.)</s1></fA11><fA11 i1="08" i2="1"><s1>RASCOL (Olivier)</s1></fA11><fA11 i1="09" i2="1"><s1>POEWE (Werner)</s1></fA11><fA11 i1="10" i2="1"><s1>TOLOSA (Eduardo)</s1></fA11><fA11 i1="11" i2="1"><s1>TRENKWALDER (Claudia)</s1></fA11><fA11 i1="12" i2="1"><s1>ONOFRJ (Marco)</s1></fA11><fA11 i1="13" i2="1"><s1>STOCCHI (Fabrizio)</s1></fA11><fA11 i1="14" i2="1"><s1>NAPPI (Giuseppe)</s1></fA11><fA11 i1="15" i2="1"><s1>KOSTIC (Vladimir)</s1></fA11><fA11 i1="16" i2="1"><s1>POTIC (Jagoda)</s1></fA11><fA11 i1="17" i2="1"><s1>RUZICKA (Evzen)</s1></fA11><fA11 i1="18" i2="1"><s1>OERTEL (Wolfgang)</s1></fA11><fA14 i1="01"><s1>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps-University Marburg</s1><s2>Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ><sZ>18 aut.</sZ></fA14><fA14 i1="02"><s1>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake</s1><s2>New Jersey</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Neurological Sciences, University of Naples Federico II-IDC Hermitage-Capodimonte</s1><s2>Naples</s2><s3>ITA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Neurology, Rheinische Friedrich-Wilhelms-University</s1><s2>Bonn</s2><s3>DEU</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Neurology, Donauspital</s1><s2>Vienna</s2><s3>AUT</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Department of Neurology, Istanbul Medical School</s1><s2>Istanbul</s2><s3>TUR</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Reta Lila Weston Institute of Neurological Studies, University College London</s1><s2>London</s2><s3>GBR</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>8 aut.</sZ></fA14><fA14 i1="10"><s1>Department of Neurology, Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>9 aut.</sZ></fA14><fA14 i1="11"><s1>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>10 aut.</sZ></fA14><fA14 i1="12"><s1>Paracelsus-Elena Klinik</s1><s2>Kassel</s2><s3>DEU</s3><sZ>11 aut.</sZ></fA14><fA14 i1="13"><s1>Clinica Neurologica, Università Chieti-Pescara</s1><s3>ITA</s3><sZ>12 aut.</sZ></fA14><fA14 i1="14"><s1>Department of Neurology, IRCCS San Raffaele</s1><s2>Rome</s2><s3>ITA</s3><sZ>13 aut.</sZ></fA14><fA14 i1="15"><s1>Chair of Neurology, University "La Sapienza</s1><s2>Rome</s2><s3>ITA</s3><sZ>14 aut.</sZ></fA14><fA14 i1="16"><s1>IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>14 aut.</sZ></fA14><fA14 i1="17"><s1>Institute of Neurology, Clinical Centre of Serbia</s1><s2>Belgrade</s2><s3>SRB</s3><sZ>15 aut.</sZ></fA14><fA14 i1="18"><s1>Clinic for Neurology and Psychiatry, Clinical Hospital Centre "Zvezdara</s1><s2>Belgrade</s2><s3>SRB</s3><sZ>16 aut.</sZ></fA14><fA14 i1="19"><s1>Department of Neurology, Charles University in Prague, 1st Faculty of Medicine and General Teaching Hospital</s1><s2>Prague</s2><s3>CZE</s3><sZ>17 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>Cooperation with the German Competence Network on Parkinson's Disease</s1><s3>INC</s3></fA17><fA20><s1>896-905</s1></fA20><fA21><s1>2010</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000193040220120</s5></fA43><fA44><s0>0000</s0><s1>© 2010 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>27 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>10-0288342</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Movement disorders</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Perampanel, a novel, noncompetitive, selective AMPA-receptor antagonist demonstrated evidence of efficacy in reducing motor symptoms in animal models of Parkinson's disease (PD). We assessed the safety and efficacy of perampanel for treatment of "wearing off" motor fluctuations in patients with PD. Patients (N = 263) were randomly assigned to once-daily add-on 0.5, 1, or 2 mg of perampanel or placebo. The primary objective was to determine whether there was a dose-response relationship for efficacy among the 3 perampanel doses and placebo. The primary efficacy endpoint for each treatment was measured as the least-squares (LS) mean change from baseline to week 12 in percent "off' time reduction during the waking day, as recorded by patient diaries. The primary efficacy analysis was a 1-sided Williams test for dose-response trend at the 0.025 level of significance. At week 12, dose-response trends, as determined by the Williams test, were not statistically significant for LS mean reduction in percent "off" time during the waking day (P = 0.061, with significance defined as P ≤ 0.025). The 2 higher perampanel doses (ITT population; n = 258) produced non-significant reductions from baseline to week 12 in percent "off" time during the waking day versus placebo (7.59%, P = 0.421 [1 mg], 8.60%, P = 0.257 [2 mg] versus 5.05% [placebo]; significance for pairwise comparisons defined as P ≤ 0.05). There were no significant changes in dyskinesia or cognitive function in any perampanel group versus placebo. Adverse events were similar across treatment groups. Perampanel treatment was well tolerated and safe, but failed to achieve statistical significance in primary and secondary endpoints.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17G</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Maladie de Parkinson</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Dyskinésie</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Dyskinesia</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Disquinesia</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Pathologie du système nerveux</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Sécurité</s0><s5>09</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Safety</s0><s5>09</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Seguridad</s0><s5>09</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Pérampanel</s0><s2>FR</s2><s5>10</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Perampanel</s0><s2>FR</s2><s5>10</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Perampanel</s0><s2>FR</s2><s5>10</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Stade avancé</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Advanced stage</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Estadio avanzado</s0><s5>11</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Placebo</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Placebo</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Placebo</s0><s5>12</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Fluctuation</s0><s5>13</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Fluctuations</s0><s5>13</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Fluctuación</s0><s5>13</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Récepteur AMPA</s0><s5>14</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>AMPA receptor</s0><s5>14</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Receptor AMPA</s0><s5>14</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Syndrome extrapyramidal</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du système nerveux central</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Mouvement involontaire</s0><s5>42</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Involuntary movement</s0><s5>42</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Movimiento involuntario</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Trouble neurologique</s0><s5>43</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Neurological disorder</s0><s5>43</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Trastorno neurológico</s0><s5>43</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Récepteur glutamate</s0><s5>44</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Glutamate receptor</s0><s5>44</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Receptor glutámato</s0><s5>44</s5></fC07><fN21><s1>186</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>Espagne</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>République tchèque</li><li>Serbie</li><li>Turquie</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bohême centrale</li><li>Catalogne</li><li>District de Cologne</li><li>District de Giessen</li><li>District de Kassel</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Latium</li><li>Midi-Pyrénées</li><li>New Jersey</li><li>Rhénanie-du-Nord-Westphalie</li><li>Tyrol (Land)</li><li>Vienne (Autriche)</li></region><settlement><li>Barcelone</li><li>Bonn</li><li>Cassel (Hesse)</li><li>Innsbruck</li><li>Londres</li><li>Marbourg</li><li>Prague</li><li>Rome</li><li>Toulouse</li><li>Vienne (Autriche)</li></settlement><orgName><li>National Hospital for Neurology and Neurosurgery</li><li>Université Toulouse III - Paul Sabatier</li><li>Université de Toulouse</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name></region><name sortKey="Dodel, Richard" sort="Dodel, Richard" uniqKey="Dodel R" first="Richard" last="Dodel">Richard Dodel</name><name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name></country><country name="États-Unis"><region name="New Jersey"><name sortKey="Squillacote, David" sort="Squillacote, David" uniqKey="Squillacote D" first="David" last="Squillacote">David Squillacote</name></region></country><country name="Italie"><noRegion><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name></noRegion><name sortKey="Nappi, Giuseppe" sort="Nappi, Giuseppe" uniqKey="Nappi G" first="Giuseppe" last="Nappi">Giuseppe Nappi</name><name sortKey="Nappi, Giuseppe" sort="Nappi, Giuseppe" uniqKey="Nappi G" first="Giuseppe" last="Nappi">Giuseppe Nappi</name><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></country><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Katzenschlager, Regina" sort="Katzenschlager, Regina" uniqKey="Katzenschlager R" first="Regina" last="Katzenschlager">Regina Katzenschlager</name></region><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></country><country name="Turquie"><noRegion><name sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew Lees (neurologue)</name></region></country><country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></region></country><country name="Serbie"><noRegion><name sortKey="Kostic, Vladimir" sort="Kostic, Vladimir" uniqKey="Kostic V" first="Vladimir" last="Kostic">Vladimir Kostic</name></noRegion><name sortKey="Potic, Jagoda" sort="Potic, Jagoda" uniqKey="Potic J" first="Jagoda" last="Potic">Jagoda Potic</name></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Ruzicka, Evzen" sort="Ruzicka, Evzen" uniqKey="Ruzicka E" first="Evzen" last="Ruzicka">Evzen Ruzicka</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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