Movement Disorders (revue)

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Perampanel, an AMPA Antagonist, Found to Have No Benefit in Reducing "Off" Time in Parkinson's Disease

Identifieur interne : 002A33 ( PascalFrancis/Curation ); précédent : 002A32; suivant : 002A34

Perampanel, an AMPA Antagonist, Found to Have No Benefit in Reducing "Off" Time in Parkinson's Disease

Auteurs : Andrew Lees [Royaume-Uni] ; Stanley Fahn [États-Unis] ; Karla M. Eggert [Allemagne] ; Joseph Jankovic [États-Unis] ; Anthony Lang [Canada] ; Federico Micheli [Argentine] ; M. Maral Mouradian [États-Unis] ; Wolfgang H. Oertel [Allemagne] ; C. Warren Olanow [États-Unis] ; Werner Poewe [Autriche] ; Olivier Rascol [France] ; Eduardo Tolosa [Espagne] ; David Squillacote [États-Unis] ; Dinesh Kumar [États-Unis]

Source :

RBID : Pascal:12-0113807

Descripteurs français

English descriptors

Abstract

Background: Perampanel is a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Two multicenter randomized, double-blind, placebo-controlled, parallel-group phase III studies assessed the efficacy and safety of adjunctive perampanel in patients with Parkinson's disease and motor fluctuations. Methods: In both phase III studies (301 and 302), levodopa-treated patients were randomized and treated with once-daily oral placebo (n = 504), perampanel 2 mg (n = 509), or perampanel 4 mg (n = 501). The primary end point was change in daily "off" time from baseline. The treatment period was 30 weeks in study 301 and 20 weeks in study 302. Results: For any efficacy end point, perampanel 2 or 4 mg was not superior to placebo. Perampanel was well tolerated up to 4 mg/day. Conclusions: Perampanel failed to significantly improve motor symptoms versus placebo. There was also no effect on the duration or disability of levodopa-induced dyskinesia.
pA  
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A08 01  1  ENG  @1 Perampanel, an AMPA Antagonist, Found to Have No Benefit in Reducing "Off" Time in Parkinson's Disease
A11 01  1    @1 LEES (Andrew)
A11 02  1    @1 FAHN (Stanley)
A11 03  1    @1 EGGERT (Karla M.)
A11 04  1    @1 JANKOVIC (Joseph)
A11 05  1    @1 LANG (Anthony)
A11 06  1    @1 MICHELI (Federico)
A11 07  1    @1 MARAL MOURADIAN (M.)
A11 08  1    @1 OERTEL (Wolfgang H.)
A11 09  1    @1 OLANOW (C. Warren)
A11 10  1    @1 POEWE (Werner)
A11 11  1    @1 RASCOL (Olivier)
A11 12  1    @1 TOLOSA (Eduardo)
A11 13  1    @1 SQUILLACOTE (David)
A11 14  1    @1 KUMAR (Dinesh)
A14 01      @1 Reta Lila Weston Institute for Neurological Studies, University College London @2 London @3 GBR @Z 1 aut.
A14 02      @1 Department of Neurology, Columbia University College of Physicians and Surgeons, New York @2 New York @3 USA @Z 2 aut.
A14 03      @1 Department of Neurology, Philipps University Marburg @2 Marburg @3 DEU @Z 3 aut. @Z 8 aut.
A14 04      @1 Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine @2 Houston, Texas @3 USA @Z 4 aut.
A14 05      @1 Toronto Western Hospital, University of Toronto @2 Toronto, Ontario @3 CAN @Z 5 aut.
A14 06      @1 Parkinson's Disease and Movement Disorders Program, Hospital de Clínicas, University of Buenos Aires @2 Buenos Aires @3 ARG @Z 6 aut.
A14 07      @1 Center for Neurodegenerative and Neuroimmunologic Diseases, Department of Neurology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School @2 Piscataway, New Jersey @3 USA @Z 7 aut.
A14 08      @1 Mount Sinai School of Medicine, New York @2 New York @3 USA @Z 9 aut.
A14 09      @1 Department of Neurology, Innsbruck Medical University @2 Innsbruck @3 AUT @Z 10 aut.
A14 10      @1 Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC9302, University of Toulouse III and University Hospital of Toulouse @2 Toulouse @3 FRA @Z 11 aut.
A14 11      @1 Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona @2 Barcelona @3 ESP @Z 12 aut.
A14 12      @1 Eisai Neuroscience Product Creation Unit @2 Woodcliff Lake, New Jersey @3 USA @Z 13 aut. @Z 14 aut.
A20       @1 284-288
A21       @1 2012
A23 01      @0 ENG
A43 01      @1 INIST @2 20953 @5 354000508698420180
A44       @0 0000 @1 © 2012 INIST-CNRS. All rights reserved.
A45       @0 14 ref.
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A60       @1 P @3 CC
A61       @0 A
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A66 01      @0 USA
C01 01    ENG  @0 Background: Perampanel is a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Two multicenter randomized, double-blind, placebo-controlled, parallel-group phase III studies assessed the efficacy and safety of adjunctive perampanel in patients with Parkinson's disease and motor fluctuations. Methods: In both phase III studies (301 and 302), levodopa-treated patients were randomized and treated with once-daily oral placebo (n = 504), perampanel 2 mg (n = 509), or perampanel 4 mg (n = 501). The primary end point was change in daily "off" time from baseline. The treatment period was 30 weeks in study 301 and 20 weeks in study 302. Results: For any efficacy end point, perampanel 2 or 4 mg was not superior to placebo. Perampanel was well tolerated up to 4 mg/day. Conclusions: Perampanel failed to significantly improve motor symptoms versus placebo. There was also no effect on the duration or disability of levodopa-induced dyskinesia.
C02 01  X    @0 002B17
C02 02  X    @0 002B17G
C03 01  X  FRE  @0 Maladie de Parkinson @2 NM @5 01
C03 01  X  ENG  @0 Parkinson disease @2 NM @5 01
C03 01  X  SPA  @0 Parkinson enfermedad @2 NM @5 01
C03 02  X  FRE  @0 Pathologie du système nerveux @5 02
C03 02  X  ENG  @0 Nervous system diseases @5 02
C03 02  X  SPA  @0 Sistema nervioso patología @5 02
C03 03  X  FRE  @0 Pérampanel @2 FR @5 09
C03 03  X  ENG  @0 Perampanel @2 FR @5 09
C03 03  X  SPA  @0 Perampanel @2 FR @5 09
C03 04  X  FRE  @0 Récepteur AMPA @5 10
C03 04  X  ENG  @0 AMPA receptor @5 10
C03 04  X  SPA  @0 Receptor AMPA @5 10
C03 05  X  FRE  @0 Fluctuation @5 11
C03 05  X  ENG  @0 Fluctuations @5 11
C03 05  X  SPA  @0 Fluctuación @5 11
C03 06  X  FRE  @0 Sécurité @5 12
C03 06  X  ENG  @0 Safety @5 12
C03 06  X  SPA  @0 Seguridad @5 12
C07 01  X  FRE  @0 Pathologie de l'encéphale @5 37
C07 01  X  ENG  @0 Cerebral disorder @5 37
C07 01  X  SPA  @0 Encéfalo patología @5 37
C07 02  X  FRE  @0 Syndrome extrapyramidal @5 38
C07 02  X  ENG  @0 Extrapyramidal syndrome @5 38
C07 02  X  SPA  @0 Extrapiramidal síndrome @5 38
C07 03  X  FRE  @0 Maladie dégénérative @5 39
C07 03  X  ENG  @0 Degenerative disease @5 39
C07 03  X  SPA  @0 Enfermedad degenerativa @5 39
C07 04  X  FRE  @0 Pathologie du système nerveux central @5 40
C07 04  X  ENG  @0 Central nervous system disease @5 40
C07 04  X  SPA  @0 Sistema nervosio central patología @5 40
C07 05  X  FRE  @0 Récepteur glutamate @5 42
C07 05  X  ENG  @0 Glutamate receptor @5 42
C07 05  X  SPA  @0 Receptor glutámato @5 42
N21       @1 086
N44 01      @1 OTO
N82       @1 OTO

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Pascal:12-0113807

Le document en format XML

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<name sortKey="Maral Mouradian, M" sort="Maral Mouradian, M" uniqKey="Maral Mouradian M" first="M." last="Maral Mouradian">M. Maral Mouradian</name>
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<name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H." last="Oertel">Wolfgang H. Oertel</name>
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<name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name>
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<name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
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<name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
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<s1>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC9302, University of Toulouse III and University Hospital of Toulouse</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>France</country>
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</author>
<author>
<name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name>
<affiliation wicri:level="1">
<inist:fA14 i1="11">
<s1>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
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</inist:fA14>
<country>Espagne</country>
</affiliation>
</author>
<author>
<name sortKey="Squillacote, David" sort="Squillacote, David" uniqKey="Squillacote D" first="David" last="Squillacote">David Squillacote</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
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<s2>Woodcliff Lake, New Jersey</s2>
<s3>USA</s3>
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</inist:fA14>
<country>États-Unis</country>
</affiliation>
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<author>
<name sortKey="Kumar, Dinesh" sort="Kumar, Dinesh" uniqKey="Kumar D" first="Dinesh" last="Kumar">Dinesh Kumar</name>
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<s1>Eisai Neuroscience Product Creation Unit</s1>
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<country>États-Unis</country>
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<title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
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<date when="2012">2012</date>
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<title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
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<term>AMPA receptor</term>
<term>Fluctuations</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Perampanel</term>
<term>Safety</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Maladie de Parkinson</term>
<term>Pathologie du système nerveux</term>
<term>Pérampanel</term>
<term>Récepteur AMPA</term>
<term>Fluctuation</term>
<term>Sécurité</term>
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<div type="abstract" xml:lang="en">Background: Perampanel is a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Two multicenter randomized, double-blind, placebo-controlled, parallel-group phase III studies assessed the efficacy and safety of adjunctive perampanel in patients with Parkinson's disease and motor fluctuations. Methods: In both phase III studies (301 and 302), levodopa-treated patients were randomized and treated with once-daily oral placebo (n = 504), perampanel 2 mg (n = 509), or perampanel 4 mg (n = 501). The primary end point was change in daily "off" time from baseline. The treatment period was 30 weeks in study 301 and 20 weeks in study 302. Results: For any efficacy end point, perampanel 2 or 4 mg was not superior to placebo. Perampanel was well tolerated up to 4 mg/day. Conclusions: Perampanel failed to significantly improve motor symptoms versus placebo. There was also no effect on the duration or disability of levodopa-induced dyskinesia.</div>
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