Safety and efficacy of perampanel in advanced Parkinson's disease: A randomized, placebo‐controlled study
Identifieur interne : 000198 ( France/Analysis ); précédent : 000197; suivant : 000199Safety 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 ] ; 2010-05-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- AMPA receptor, AMPA receptor antagonist, Adult, Advanced stage, Aged, Antiparkinson Agents (adverse effects), Antiparkinson Agents (therapeutic use), Double-Blind Method, Dyskinesia, Female, Fluctuations, Humans, Male, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson Disease (physiopathology), Parkinson disease, Parkinson's disease, Perampanel, Placebo, Pyridones (therapeutic use), Receptors, AMPA (antagonists & inhibitors), Safety, Treatment Outcome, dyskinesia, motor fluctuations, perampanel.
- MESH :
- chemical , adverse effects : Antiparkinson Agents.
- chemical , antagonists & inhibitors : Receptors, AMPA.
- chemical , therapeutic use : Antiparkinson Agents, Pyridones.
- drug therapy : Parkinson Disease.
- physiopathology : Parkinson Disease.
- Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome.
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 nonsignificant 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. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.22974
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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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"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake, New Jersey</wicri:regionArea><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"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Naples Federico II‐IDC Hermitage‐Capodimonte, Naples</wicri:regionArea><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"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Rheinische Friedrich‐Wilhelms‐University, Bonn</wicri:regionArea><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"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Donauspital, Vienna</wicri:regionArea><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"><country xml:lang="fr">Turquie</country><wicri:regionArea>Department of Neurology, Istanbul Medical School, Istanbul</wicri:regionArea><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"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Reta Lila Weston Institute of Neurological Studies, University College London, London</wicri:regionArea><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"><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse, Toulouse</wicri:regionArea><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"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse, Toulouse</wicri:regionArea><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"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Medical University Innsbruck, Innsbruck</wicri:regionArea><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"><country xml:lang="fr">Espagne</country><wicri:regionArea>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED, Barcelona</wicri:regionArea><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"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paracelsus‐Elena Klinik, Kassel</wicri:regionArea><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"><country xml:lang="fr">Italie</country><wicri:regionArea>Clinica Neurologica, Università Chieti‐Pescara</wicri:regionArea><wicri:noRegion>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"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, IRCCS San Raffaele, Rome</wicri:regionArea><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="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Chair of Neurology, University “La Sapienza,” Rome</wicri:regionArea><wicri:noRegion>” Rome</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia</wicri:regionArea><wicri:noRegion>Pavia</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"><country xml:lang="fr">Serbie</country><wicri:regionArea>Institute of Neurology, Clinical Centre of Serbia, Belgrade</wicri:regionArea><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"><country xml:lang="fr">Serbie</country><wicri:regionArea>Clinic for Neurology and Psychiatry, Clinical Hospital Centre “Zvezdara,” Belgrade</wicri:regionArea><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"><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Neurology, Charles University in Prague, 1st Faculty of Medicine and General Teaching Hospital, Prague</wicri:regionArea><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"><country xml:lang="fr">Allemagne</country><wicri:regionArea>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg</wicri:regionArea><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><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-05-15">2010-05-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="896">896</biblScope><biblScope unit="page" to="905">905</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">F3991B9F741986E5D89C72FDB4FA8C332024F02F</idno><idno type="DOI">10.1002/mds.22974</idno><idno type="ArticleID">MDS22974</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AMPA receptor</term><term>AMPA receptor antagonist</term><term>Adult</term><term>Advanced stage</term><term>Aged</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Dyskinesia</term><term>Female</term><term>Fluctuations</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (physiopathology)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Perampanel</term><term>Placebo</term><term>Pyridones (therapeutic use)</term><term>Receptors, AMPA (antagonists & inhibitors)</term><term>Safety</term><term>Treatment Outcome</term><term>dyskinesia</term><term>motor fluctuations</term><term>perampanel</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Receptors, AMPA</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Pyridones</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Dyskinésie</term><term>Fluctuation</term><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Placebo</term><term>Pérampanel</term><term>Récepteur AMPA</term><term>Stade avancé</term><term>Sécurité</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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 nonsignificant 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. © 2010 Movement Disorder Society</div></front></TEI><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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