Safety and efficacy of perampanel in advanced Parkinson's disease: A randomized, placebo‐controlled study
Identifieur interne : 000052 ( Istex/Curation ); précédent : 000051; suivant : 000053Safety 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 J. Lees [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.
English descriptors
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
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DOI: 10.1002/mds.22974
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">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="1"><mods:affiliation>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg</wicri:regionArea></affiliation></author><author><name sortKey="Squillacote, David" sort="Squillacote, David" uniqKey="Squillacote D" first="David" last="Squillacote">David Squillacote</name><affiliation wicri:level="1"><mods:affiliation>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake, New Jersey, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake, New Jersey</wicri:regionArea></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurological Sciences, University of Naples Federico II‐IDC Hermitage‐Capodimonte, Naples, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Naples Federico II‐IDC Hermitage‐Capodimonte, Naples</wicri:regionArea></affiliation></author><author><name sortKey="Dodel, Richard" sort="Dodel, Richard" uniqKey="Dodel R" first="Richard" last="Dodel">Richard Dodel</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Rheinische Friedrich‐Wilhelms‐University, Bonn, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Rheinische Friedrich‐Wilhelms‐University, Bonn</wicri:regionArea></affiliation></author><author><name sortKey="Katzenschlager, Regina" sort="Katzenschlager, Regina" uniqKey="Katzenschlager R" first="Regina" last="Katzenschlager">Regina Katzenschlager</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Donauspital, Vienna, Austria</mods:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Donauspital, Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Istanbul Medical School, Istanbul, Turkey</mods:affiliation><country xml:lang="fr">Turquie</country><wicri:regionArea>Department of Neurology, Istanbul Medical School, Istanbul</wicri:regionArea></affiliation></author><author><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew J. Lees</name><affiliation wicri:level="1"><mods:affiliation>Reta Lila Weston Institute of Neurological Studies, University College London, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Reta Lila Weston Institute of Neurological Studies, University College London, London</wicri:regionArea></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><mods:affiliation>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse, Toulouse, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse, Toulouse</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse, Toulouse, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse, Toulouse</wicri:regionArea></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</mods:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Medical University Innsbruck, Innsbruck</wicri:regionArea></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="1"><mods:affiliation>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED, Barcelona, Spain</mods:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><affiliation wicri:level="1"><mods:affiliation>Paracelsus‐Elena Klinik, Kassel, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paracelsus‐Elena Klinik, Kassel</wicri:regionArea></affiliation></author><author><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name><affiliation wicri:level="1"><mods:affiliation>Clinica Neurologica, Università Chieti‐Pescara, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Clinica Neurologica, Università Chieti‐Pescara</wicri:regionArea></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, IRCCS San Raffaele, Rome, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, IRCCS San Raffaele, Rome</wicri:regionArea></affiliation></author><author><name sortKey="Nappi, Giuseppe" sort="Nappi, Giuseppe" uniqKey="Nappi G" first="Giuseppe" last="Nappi">Giuseppe Nappi</name><affiliation wicri:level="1"><mods:affiliation>Chair of Neurology, University “La Sapienza,” Rome, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Chair of Neurology, University “La Sapienza,” Rome</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia</wicri:regionArea></affiliation></author><author><name sortKey="Kostic, Vladimir" sort="Kostic, Vladimir" uniqKey="Kostic V" first="Vladimir" last="Kostic">Vladimir Kostic</name><affiliation wicri:level="1"><mods:affiliation>Institute of Neurology, Clinical Centre of Serbia, Belgrade, Serbia</mods:affiliation><country xml:lang="fr">Serbie</country><wicri:regionArea>Institute of Neurology, Clinical Centre of Serbia, Belgrade</wicri:regionArea></affiliation></author><author><name sortKey="Potic, Jagoda" sort="Potic, Jagoda" uniqKey="Potic J" first="Jagoda" last="Potic">Jagoda Potic</name><affiliation wicri:level="1"><mods:affiliation>Clinic for Neurology and Psychiatry, Clinical Hospital Centre “Zvezdara,” Belgrade, Serbia</mods:affiliation><country xml:lang="fr">Serbie</country><wicri:regionArea>Clinic for Neurology and Psychiatry, Clinical Hospital Centre “Zvezdara,” Belgrade</wicri:regionArea></affiliation></author><author><name sortKey="Ruzicka, Evzen" sort="Ruzicka, Evzen" uniqKey="Ruzicka E" first="Evzen" last="Ruzicka">Evzen Ruzicka</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Charles University in Prague, 1st Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic</mods:affiliation><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></affiliation></author><author><name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name><affiliation wicri:level="1"><mods:affiliation>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:F3991B9F741986E5D89C72FDB4FA8C332024F02F</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1002/mds.22974</idno><idno type="url">https://api.istex.fr/document/F3991B9F741986E5D89C72FDB4FA8C332024F02F/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000052</idno><idno type="wicri:Area/Istex/Curation">000052</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">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="1"><mods:affiliation>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg</wicri:regionArea></affiliation></author><author><name sortKey="Squillacote, David" sort="Squillacote, David" uniqKey="Squillacote D" first="David" last="Squillacote">David Squillacote</name><affiliation wicri:level="1"><mods:affiliation>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake, New Jersey, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eisai Global Clinical Development, Eisai Medical Research Inc., Woodcliff Lake, New Jersey</wicri:regionArea></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurological Sciences, University of Naples Federico II‐IDC Hermitage‐Capodimonte, Naples, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Naples Federico II‐IDC Hermitage‐Capodimonte, Naples</wicri:regionArea></affiliation></author><author><name sortKey="Dodel, Richard" sort="Dodel, Richard" uniqKey="Dodel R" first="Richard" last="Dodel">Richard Dodel</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Rheinische Friedrich‐Wilhelms‐University, Bonn, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, Rheinische Friedrich‐Wilhelms‐University, Bonn</wicri:regionArea></affiliation></author><author><name sortKey="Katzenschlager, Regina" sort="Katzenschlager, Regina" uniqKey="Katzenschlager R" first="Regina" last="Katzenschlager">Regina Katzenschlager</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Donauspital, Vienna, Austria</mods:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Donauspital, Vienna</wicri:regionArea></affiliation></author><author><name sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Istanbul Medical School, Istanbul, Turkey</mods:affiliation><country xml:lang="fr">Turquie</country><wicri:regionArea>Department of Neurology, Istanbul Medical School, Istanbul</wicri:regionArea></affiliation></author><author><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew J. Lees</name><affiliation wicri:level="1"><mods:affiliation>Reta Lila Weston Institute of Neurological Studies, University College London, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Reta Lila Weston Institute of Neurological Studies, University College London, London</wicri:regionArea></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><mods:affiliation>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse, Toulouse, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Center, INSERM CIC9302, University Hospital Toulouse, Toulouse</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse, Toulouse, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM UMR825, University Hospital Toulouse, Toulouse</wicri:regionArea></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Medical University Innsbruck, Innsbruck, Austria</mods:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Medical University Innsbruck, Innsbruck</wicri:regionArea></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="1"><mods:affiliation>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED, Barcelona, Spain</mods:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Neurology Service, Hospital Clinic, Universitat de Barcelona, CIBERNED, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><affiliation wicri:level="1"><mods:affiliation>Paracelsus‐Elena Klinik, Kassel, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paracelsus‐Elena Klinik, Kassel</wicri:regionArea></affiliation></author><author><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name><affiliation wicri:level="1"><mods:affiliation>Clinica Neurologica, Università Chieti‐Pescara, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Clinica Neurologica, Università Chieti‐Pescara</wicri:regionArea></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, IRCCS San Raffaele, Rome, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurology, IRCCS San Raffaele, Rome</wicri:regionArea></affiliation></author><author><name sortKey="Nappi, Giuseppe" sort="Nappi, Giuseppe" uniqKey="Nappi G" first="Giuseppe" last="Nappi">Giuseppe Nappi</name><affiliation wicri:level="1"><mods:affiliation>Chair of Neurology, University “La Sapienza,” Rome, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Chair of Neurology, University “La Sapienza,” Rome</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</mods:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia</wicri:regionArea></affiliation></author><author><name sortKey="Kostic, Vladimir" sort="Kostic, Vladimir" uniqKey="Kostic V" first="Vladimir" last="Kostic">Vladimir Kostic</name><affiliation wicri:level="1"><mods:affiliation>Institute of Neurology, Clinical Centre of Serbia, Belgrade, Serbia</mods:affiliation><country xml:lang="fr">Serbie</country><wicri:regionArea>Institute of Neurology, Clinical Centre of Serbia, Belgrade</wicri:regionArea></affiliation></author><author><name sortKey="Potic, Jagoda" sort="Potic, Jagoda" uniqKey="Potic J" first="Jagoda" last="Potic">Jagoda Potic</name><affiliation wicri:level="1"><mods:affiliation>Clinic for Neurology and Psychiatry, Clinical Hospital Centre “Zvezdara,” Belgrade, Serbia</mods:affiliation><country xml:lang="fr">Serbie</country><wicri:regionArea>Clinic for Neurology and Psychiatry, Clinical Hospital Centre “Zvezdara,” Belgrade</wicri:regionArea></affiliation></author><author><name sortKey="Ruzicka, Evzen" sort="Ruzicka, Evzen" uniqKey="Ruzicka E" first="Evzen" last="Ruzicka">Evzen Ruzicka</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Charles University in Prague, 1st Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic</mods:affiliation><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></affiliation></author><author><name sortKey="Oertel, Wolfgang" sort="Oertel, Wolfgang" uniqKey="Oertel W" first="Wolfgang" last="Oertel">Wolfgang Oertel</name><affiliation wicri:level="1"><mods:affiliation>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>German Competence Network on Parkinson's Disease, Department of Neurology, Philipps‐University Marburg, Marburg</wicri:regionArea></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 antagonist</term><term>Parkinson's disease</term><term>dyskinesia</term><term>motor fluctuations</term><term>perampanel</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></record>Pour manipuler ce document sous Unix (Dilib)
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