La maladie de Parkinson au Canada (serveur d'exploration)

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A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.

Identifieur interne : 000211 ( PubMed/Corpus ); précédent : 000210; suivant : 000212

A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.

Auteurs : Claudia Trenkwalder ; Daniela Berg ; Olivier Rascol ; Karla Eggert ; Andres Ceballos-Baumann ; Jean-Christophe Corvol ; Alexander Storch ; Lin Zhang ; Jean-Philippe Azulay ; Emmanuel Broussolle ; Luc Defebvre ; Christian Geny ; Michal Gostkowski ; Fabrizio Stocchi ; Christine Tranchant ; Pascal Derkinderen ; Franck Durif ; Alberto J. Espay ; Andrew Feigin ; Jean-Luc Houeto ; Johannes Schwarz ; Thérèse Di Paolo ; Dominik Feuerbach ; Hans-Ulrich Hockey ; Judith Jaeger ; Annamaria Jakab ; Donald Johns ; Gurutz Linazasoro ; Paul Maruff ; Izabela Rozenberg ; Judit Sovago ; Markus Weiss ; Baltazar Gomez-Mancilla

Source :

RBID : pubmed:26990766

Abstract

This phase 2 randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the nicotinic acetylcholine receptor α7 agonist AQW051 in patients with Parkinson's disease and levodopa-induced dyskinesia.

DOI: 10.1002/mds.26569
PubMed: 26990766

Links to Exploration step

pubmed:26990766

Le document en format XML

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<name sortKey="Berg, Daniela" sort="Berg, Daniela" uniqKey="Berg D" first="Daniela" last="Berg">Daniela Berg</name>
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<nlm:affiliation>Department of Clinical Pharmacology and Neurosciences, NeuroToul Excellence Center for Neurodegenerative Disorders, University UPS of Toulouse III, CIC-9302/INSERM UMR825, Hôpital Purpan - Pavillon Riser, Toulouse, France.</nlm:affiliation>
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<name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name>
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<name sortKey="Ceballos Baumann, Andres" sort="Ceballos Baumann, Andres" uniqKey="Ceballos Baumann A" first="Andres" last="Ceballos-Baumann">Andres Ceballos-Baumann</name>
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<name sortKey="Corvol, Jean Christophe" sort="Corvol, Jean Christophe" uniqKey="Corvol J" first="Jean-Christophe" last="Corvol">Jean-Christophe Corvol</name>
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<name sortKey="Defebvre, Luc" sort="Defebvre, Luc" uniqKey="Defebvre L" first="Luc" last="Defebvre">Luc Defebvre</name>
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<name sortKey="Geny, Christian" sort="Geny, Christian" uniqKey="Geny C" first="Christian" last="Geny">Christian Geny</name>
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<name sortKey="Gostkowski, Michal" sort="Gostkowski, Michal" uniqKey="Gostkowski M" first="Michal" last="Gostkowski">Michal Gostkowski</name>
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<name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name>
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<nlm:affiliation>Department of Neurology, Institute for Research and Medical Care, IROCS, Rome, Italy.</nlm:affiliation>
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<name sortKey="Tranchant, Christine" sort="Tranchant, Christine" uniqKey="Tranchant C" first="Christine" last="Tranchant">Christine Tranchant</name>
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<name sortKey="Derkinderen, Pascal" sort="Derkinderen, Pascal" uniqKey="Derkinderen P" first="Pascal" last="Derkinderen">Pascal Derkinderen</name>
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<name sortKey="Feigin, Andrew" sort="Feigin, Andrew" uniqKey="Feigin A" first="Andrew" last="Feigin">Andrew Feigin</name>
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<name sortKey="Houeto, Jean Luc" sort="Houeto, Jean Luc" uniqKey="Houeto J" first="Jean-Luc" last="Houeto">Jean-Luc Houeto</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
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<name sortKey="Schwarz, Johannes" sort="Schwarz, Johannes" uniqKey="Schwarz J" first="Johannes" last="Schwarz">Johannes Schwarz</name>
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<nlm:affiliation>German Parkinson Study Group, Marburg, Germany.</nlm:affiliation>
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<name sortKey="Di Paolo, Therese" sort="Di Paolo, Therese" uniqKey="Di Paolo T" first="Thérèse" last="Di Paolo">Thérèse Di Paolo</name>
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<nlm:affiliation>Neuroscience Research Unit, Centre de recherche du CHU de Québec, Québec, Canada.</nlm:affiliation>
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<name sortKey="Feuerbach, Dominik" sort="Feuerbach, Dominik" uniqKey="Feuerbach D" first="Dominik" last="Feuerbach">Dominik Feuerbach</name>
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<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
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<name sortKey="Hockey, Hans Ulrich" sort="Hockey, Hans Ulrich" uniqKey="Hockey H" first="Hans-Ulrich" last="Hockey">Hans-Ulrich Hockey</name>
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<name sortKey="Jaeger, Judith" sort="Jaeger, Judith" uniqKey="Jaeger J" first="Judith" last="Jaeger">Judith Jaeger</name>
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<name sortKey="Maruff, Paul" sort="Maruff, Paul" uniqKey="Maruff P" first="Paul" last="Maruff">Paul Maruff</name>
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<name sortKey="Rozenberg, Izabela" sort="Rozenberg, Izabela" uniqKey="Rozenberg I" first="Izabela" last="Rozenberg">Izabela Rozenberg</name>
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<name sortKey="Sovago, Judit" sort="Sovago, Judit" uniqKey="Sovago J" first="Judit" last="Sovago">Judit Sovago</name>
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<name sortKey="Weiss, Markus" sort="Weiss, Markus" uniqKey="Weiss M" first="Markus" last="Weiss">Markus Weiss</name>
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<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
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<name sortKey="Gomez Mancilla, Baltazar" sort="Gomez Mancilla, Baltazar" uniqKey="Gomez Mancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
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<title xml:lang="en">A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.</title>
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<nlm:affiliation>Paracelsus-Elena Hospital, Kassel, Germany.</nlm:affiliation>
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<name sortKey="Berg, Daniela" sort="Berg, Daniela" uniqKey="Berg D" first="Daniela" last="Berg">Daniela Berg</name>
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<nlm:affiliation>German Parkinson Study Group, Marburg, Germany.</nlm:affiliation>
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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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<nlm:affiliation>Department of Clinical Pharmacology and Neurosciences, NeuroToul Excellence Center for Neurodegenerative Disorders, University UPS of Toulouse III, CIC-9302/INSERM UMR825, Hôpital Purpan - Pavillon Riser, Toulouse, France.</nlm:affiliation>
</affiliation>
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<name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name>
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<nlm:affiliation>German Parkinson Study Group, Marburg, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Ceballos Baumann, Andres" sort="Ceballos Baumann, Andres" uniqKey="Ceballos Baumann A" first="Andres" last="Ceballos-Baumann">Andres Ceballos-Baumann</name>
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<nlm:affiliation>German Parkinson Study Group, Marburg, Germany.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Corvol, Jean Christophe" sort="Corvol, Jean Christophe" uniqKey="Corvol J" first="Jean-Christophe" last="Corvol">Jean-Christophe Corvol</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
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<name sortKey="Storch, Alexander" sort="Storch, Alexander" uniqKey="Storch A" first="Alexander" last="Storch">Alexander Storch</name>
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<nlm:affiliation>German Parkinson Study Group, Marburg, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Zhang, Lin" sort="Zhang, Lin" uniqKey="Zhang L" first="Lin" last="Zhang">Lin Zhang</name>
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<nlm:affiliation>Department of Neurology, UC Davis MIND Institute, Sacramento, California, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Azulay, Jean Philippe" sort="Azulay, Jean Philippe" uniqKey="Azulay J" first="Jean-Philippe" last="Azulay">Jean-Philippe Azulay</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Broussolle, Emmanuel" sort="Broussolle, Emmanuel" uniqKey="Broussolle E" first="Emmanuel" last="Broussolle">Emmanuel Broussolle</name>
<affiliation>
<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Defebvre, Luc" sort="Defebvre, Luc" uniqKey="Defebvre L" first="Luc" last="Defebvre">Luc Defebvre</name>
<affiliation>
<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Geny, Christian" sort="Geny, Christian" uniqKey="Geny C" first="Christian" last="Geny">Christian Geny</name>
<affiliation>
<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Gostkowski, Michal" sort="Gostkowski, Michal" uniqKey="Gostkowski M" first="Michal" last="Gostkowski">Michal Gostkowski</name>
<affiliation>
<nlm:affiliation>Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name>
<affiliation>
<nlm:affiliation>Department of Neurology, Institute for Research and Medical Care, IROCS, Rome, Italy.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Tranchant, Christine" sort="Tranchant, Christine" uniqKey="Tranchant C" first="Christine" last="Tranchant">Christine Tranchant</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Derkinderen, Pascal" sort="Derkinderen, Pascal" uniqKey="Derkinderen P" first="Pascal" last="Derkinderen">Pascal Derkinderen</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Durif, Franck" sort="Durif, Franck" uniqKey="Durif F" first="Franck" last="Durif">Franck Durif</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
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<name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J" last="Espay">Alberto J. Espay</name>
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<nlm:affiliation>Department of Neurology, James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Feigin, Andrew" sort="Feigin, Andrew" uniqKey="Feigin A" first="Andrew" last="Feigin">Andrew Feigin</name>
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<nlm:affiliation>Feinstein Institute for Medical Research, North Shore - LIJ Health System, Manhasset, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Houeto, Jean Luc" sort="Houeto, Jean Luc" uniqKey="Houeto J" first="Jean-Luc" last="Houeto">Jean-Luc Houeto</name>
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<nlm:affiliation>NS PARK/FCRIN Network, France.</nlm:affiliation>
</affiliation>
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<name sortKey="Schwarz, Johannes" sort="Schwarz, Johannes" uniqKey="Schwarz J" first="Johannes" last="Schwarz">Johannes Schwarz</name>
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<nlm:affiliation>German Parkinson Study Group, Marburg, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Di Paolo, Therese" sort="Di Paolo, Therese" uniqKey="Di Paolo T" first="Thérèse" last="Di Paolo">Thérèse Di Paolo</name>
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<nlm:affiliation>Neuroscience Research Unit, Centre de recherche du CHU de Québec, Québec, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Feuerbach, Dominik" sort="Feuerbach, Dominik" uniqKey="Feuerbach D" first="Dominik" last="Feuerbach">Dominik Feuerbach</name>
<affiliation>
<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Hockey, Hans Ulrich" sort="Hockey, Hans Ulrich" uniqKey="Hockey H" first="Hans-Ulrich" last="Hockey">Hans-Ulrich Hockey</name>
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<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Jaeger, Judith" sort="Jaeger, Judith" uniqKey="Jaeger J" first="Judith" last="Jaeger">Judith Jaeger</name>
<affiliation>
<nlm:affiliation>Albert Einstein College of Medicine, New York, NY, USA, and CognitionMetrics, LLC, Wilmington, Delaware, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Jakab, Annamaria" sort="Jakab, Annamaria" uniqKey="Jakab A" first="Annamaria" last="Jakab">Annamaria Jakab</name>
<affiliation>
<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Johns, Donald" sort="Johns, Donald" uniqKey="Johns D" first="Donald" last="Johns">Donald Johns</name>
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<nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Linazasoro, Gurutz" sort="Linazasoro, Gurutz" uniqKey="Linazasoro G" first="Gurutz" last="Linazasoro">Gurutz Linazasoro</name>
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</affiliation>
</author>
<author>
<name sortKey="Maruff, Paul" sort="Maruff, Paul" uniqKey="Maruff P" first="Paul" last="Maruff">Paul Maruff</name>
<affiliation>
<nlm:affiliation>CogState, Inc, New Haven, Connecticut, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Rozenberg, Izabela" sort="Rozenberg, Izabela" uniqKey="Rozenberg I" first="Izabela" last="Rozenberg">Izabela Rozenberg</name>
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<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Sovago, Judit" sort="Sovago, Judit" uniqKey="Sovago J" first="Judit" last="Sovago">Judit Sovago</name>
<affiliation>
<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Weiss, Markus" sort="Weiss, Markus" uniqKey="Weiss M" first="Markus" last="Weiss">Markus Weiss</name>
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<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Gomez Mancilla, Baltazar" sort="Gomez Mancilla, Baltazar" uniqKey="Gomez Mancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
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<nlm:affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</nlm:affiliation>
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<title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
<idno type="eISSN">1531-8257</idno>
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<front>
<div type="abstract" xml:lang="en">This phase 2 randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the nicotinic acetylcholine receptor α7 agonist AQW051 in patients with Parkinson's disease and levodopa-induced dyskinesia.</div>
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<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">This phase 2 randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the nicotinic acetylcholine receptor α7 agonist AQW051 in patients with Parkinson's disease and levodopa-induced dyskinesia.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients with idiopathic Parkinson's disease and moderate to severe levodopa-induced dyskinesia were randomized to AQW051 10 mg (n = 24), AQW051 50 mg (n = 24), or placebo (n = 23) once daily for 28 days. Coprimary end points were change in Modified Abnormal Involuntary Movement Scale and Unified Parkinson's Disease Rating Scale part III scores. Secondary outcomes included pharmacokinetics.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">In total, 67 patients completed the study. AQW051-treated patients experienced no significant improvements in Modified Abnormal Involuntary Movement Scale or Unified Parkinson's Disease Rating Scale part III scores by day 28. AQW051 was well tolerated; the most common adverse events were dyskinesia, fatigue, nausea, and falls.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">AQW051 did not significantly reduce dyskinesia or parkinsonian severity. © 2016 International Parkinson and Movement Disorder Society.</AbstractText>
<CopyrightInformation>© 2016 International Parkinson and Movement Disorder Society.</CopyrightInformation>
</Abstract>
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<LastName>Trenkwalder</LastName>
<ForeName>Claudia</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Paracelsus-Elena Hospital, Kassel, Germany.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Department of Neurosurgery, University Medical Center, Goettingen, Germany.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>German Parkinson Study Group, Marburg, Germany.</Affiliation>
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<LastName>Berg</LastName>
<ForeName>Daniela</ForeName>
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<AffiliationInfo>
<Affiliation>Department of Neurodegeneration, Hertie-Institute for Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen, Germany.</Affiliation>
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<Affiliation>German Parkinson Study Group, Marburg, Germany.</Affiliation>
</AffiliationInfo>
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<Affiliation>Department of Neurology, Philipps-University of Marburg, Marburg, Germany.</Affiliation>
</AffiliationInfo>
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<LastName>Ceballos-Baumann</LastName>
<ForeName>Andres</ForeName>
<Initials>A</Initials>
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<Affiliation>German Parkinson Study Group, Marburg, Germany.</Affiliation>
</AffiliationInfo>
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<Affiliation>Schön Klinik München-Schwabing, München, Germany.</Affiliation>
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<ForeName>Jean-Christophe</ForeName>
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</AffiliationInfo>
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<Affiliation>Sorbonne Universités, UPMC Univ Paris 06, and INSERM UMRS 1127 /CIC-1422, and CNRS UMR 7225, and AP-HP, and ICM, Hôpital Pitié-Salpêtrière, Département des maladies du système nerveux, Paris, France.</Affiliation>
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<Initials>A</Initials>
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<Affiliation>Division of Neurodegenerative Diseases, Department of Neurology, Dresden University of Technology, Dresden, Germany.</Affiliation>
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<LastName>Zhang</LastName>
<ForeName>Lin</ForeName>
<Initials>L</Initials>
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<Affiliation>Department of Neurology, UC Davis MIND Institute, Sacramento, California, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Azulay</LastName>
<ForeName>Jean-Philippe</ForeName>
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<Affiliation>Univisité Lyon 1, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, Service de Neurologie C, Lyon, France.</Affiliation>
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<Affiliation>Faculty of Pharmacy, Laval University, Québec, Canada.</Affiliation>
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<Initials>D</Initials>
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<Affiliation>Biometrics Matters Ltd, Hamilton, New Zealand.</Affiliation>
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<LastName>Weiss</LastName>
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<LastName>Gomez-Mancilla</LastName>
<ForeName>Baltazar</ForeName>
<Initials>B</Initials>
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<Affiliation>Novartis Institutes for BioMedical Research, Basel, Switzerland.</Affiliation>
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<AffiliationInfo>
<Affiliation>Department of Neurology and Neurosurgery, McGill University, Montreal, Québec, Canada.</Affiliation>
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<Day>15</Day>
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<MedlineTA>Mov Disord</MedlineTA>
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<Keyword MajorTopicYN="N">dyskinesias</Keyword>
<Keyword MajorTopicYN="N">levodopa (l-dopa)</Keyword>
<Keyword MajorTopicYN="N">nicotinic acetylcholine receptor agonist (nAChR) α7</Keyword>
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<Month>11</Month>
<Day>06</Day>
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<Year>2016</Year>
<Month>01</Month>
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<Month>01</Month>
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<Month>3</Month>
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