AFQ056 treatment of levodopa‐induced dyskinesias: Results of 2 randomized controlled trials
Identifieur interne : 001882 ( Main/Merge ); précédent : 001881; suivant : 001883AFQ056 treatment of levodopa‐induced dyskinesias: Results of 2 randomized controlled trials
Auteurs : Daniela Berg [Allemagne] ; Jana Godau [Allemagne] ; Claudia Trenkwalder [Allemagne] ; Karla Eggert [Allemagne] ; Iiona Csoti [Allemagne] ; Alexander Storch [Allemagne] ; Heiko Huber [Allemagne] ; Monica Morelli-Canelo [Allemagne] ; Maria Stamelou [Allemagne] ; Vincent Ries [Allemagne] ; Martin Wolz [Allemagne] ; Christine Schneider [Allemagne] ; Thérèse Di Paolo [Canada] ; Fabrizio Gasparini [Suisse] ; Sam Hariry [Suisse] ; Marc Vandemeulebroecke [Suisse] ; Walid Abi-Saab [Suisse] ; Katy Cooke [Royaume-Uni] ; Donald Johns [Suisse] ; Baltazar Gomez-Mancilla [Suisse]Source :
- Movement Disorders [ 0885-3185 ] ; 2011-06.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiparkinson Agents (adverse effects), Drug Interactions, Dyskinesia, Drug-Induced (drug therapy), Excitatory Amino Acid Antagonists (administration & dosage), Excitatory Amino Acid Antagonists (adverse effects), Female, Follow-Up Studies, Humans, Levodopa (adverse effects), Male, Middle Aged, Parkinson Disease (drug therapy), Receptor, Metabotropic Glutamate 5, Receptors, Metabotropic Glutamate (antagonists & inhibitors), Treatment Outcome, dyskinesias, glutamate antagonists, levodopa, parkinsonism.
- MESH :
- chemical , administration & dosage : Excitatory Amino Acid Antagonists.
- chemical , adverse effects : Antiparkinson Agents, Excitatory Amino Acid Antagonists, Levodopa.
- chemical , antagonists & inhibitors : Receptors, Metabotropic Glutamate.
- drug therapy : Dyskinesia, Drug-Induced, Parkinson Disease.
- Adult, Aged, Aged, 80 and over, Drug Interactions, Female, Follow-Up Studies, Humans, Male, Middle Aged, Receptor, Metabotropic Glutamate 5, Treatment Outcome.
Abstract
Study objectives were to assess the efficacy, safety, and tolerability of AFQ056 in Parkinson's disease patients with levodopa‐induced dyskinesia. Two randomized, double‐blind, placebo‐controlled, parallel‐group, in‐patient studies for Parkinson's disease patients with moderate to severe levodopa‐induced dyskinesia (study 1) and severe levodopa‐induced dyskinesia (study 2) on stable dopaminergic therapy were performed. Patients received 25–150 mg AFQ056 or placebo twice daily for 16 days (both studies). Study 2 included a 4‐day down‐titration. Primary outcomes were the Lang‐Fahn Activities of Daily Living Dyskinesia Scale (study 1), the modified Abnormal Involuntary Movement Scale (study 2), and the Unified Parkinson's Disease Rating Scale–part III (both studies). Secondary outcomes included the Unified Parkinson's Disease Rating Scale–part IV items 32–33. The primary analysis was change from baseline to day 16 on all outcomes. Treatment differences were assessed. Fifteen patients were randomized to AFQ056 and 16 to placebo in study 1; 14 patients were randomized to each group in study 2. AFQ056‐treated patients showed significant improvements in dyskinesias on day 16 versus placebo (eg, Lang‐Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1]; modified Abnormal Involuntary Movement Scale, P = .032 [study 2]). No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale‐part III in either study. Adverse events were reported in both studies, including dizziness. Serious adverse events (most commonly worsening of dyskinesias, apparently associated with stopping treatment) were reported by 4 AFQ056‐treated patients in study 1, and 3 patients (2 AFQ056‐treated patient and 1 in the placebo group) in study 2. AFQ056 showed a clinically relevant and significant antidyskinetic effect without changing the antiparkinsonian effects of dopaminergic therapy. © 2011 Movement Disorder Society
Url:
DOI: 10.1002/mds.23616
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<term>Drug Interactions</term>
<term>Dyskinesia, Drug-Induced (drug therapy)</term>
<term>Excitatory Amino Acid Antagonists (administration & dosage)</term>
<term>Excitatory Amino Acid Antagonists (adverse effects)</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Levodopa (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Receptor, Metabotropic Glutamate 5</term>
<term>Receptors, Metabotropic Glutamate (antagonists & inhibitors)</term>
<term>Treatment Outcome</term>
<term>dyskinesias</term>
<term>glutamate antagonists</term>
<term>levodopa</term>
<term>parkinsonism</term>
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<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Drug Interactions</term>
<term>Female</term>
<term>Follow-Up Studies</term>
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<front><div type="abstract" xml:lang="en">Study objectives were to assess the efficacy, safety, and tolerability of AFQ056 in Parkinson's disease patients with levodopa‐induced dyskinesia. Two randomized, double‐blind, placebo‐controlled, parallel‐group, in‐patient studies for Parkinson's disease patients with moderate to severe levodopa‐induced dyskinesia (study 1) and severe levodopa‐induced dyskinesia (study 2) on stable dopaminergic therapy were performed. Patients received 25–150 mg AFQ056 or placebo twice daily for 16 days (both studies). Study 2 included a 4‐day down‐titration. Primary outcomes were the Lang‐Fahn Activities of Daily Living Dyskinesia Scale (study 1), the modified Abnormal Involuntary Movement Scale (study 2), and the Unified Parkinson's Disease Rating Scale–part III (both studies). Secondary outcomes included the Unified Parkinson's Disease Rating Scale–part IV items 32–33. The primary analysis was change from baseline to day 16 on all outcomes. Treatment differences were assessed. Fifteen patients were randomized to AFQ056 and 16 to placebo in study 1; 14 patients were randomized to each group in study 2. AFQ056‐treated patients showed significant improvements in dyskinesias on day 16 versus placebo (eg, Lang‐Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1]; modified Abnormal Involuntary Movement Scale, P = .032 [study 2]). No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale‐part III in either study. Adverse events were reported in both studies, including dizziness. Serious adverse events (most commonly worsening of dyskinesias, apparently associated with stopping treatment) were reported by 4 AFQ056‐treated patients in study 1, and 3 patients (2 AFQ056‐treated patient and 1 in the placebo group) in study 2. AFQ056 showed a clinically relevant and significant antidyskinetic effect without changing the antiparkinsonian effects of dopaminergic therapy. © 2011 Movement Disorder Society</div>
</front>
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<author><name sortKey="Berg, Daniela" sort="Berg, Daniela" uniqKey="Berg D" first="Daniela" last="Berg">Daniela Berg</name>
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<author><name sortKey="Godau, Jana" sort="Godau, Jana" uniqKey="Godau J" first="Jana" last="Godau">Jana Godau</name>
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<author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name>
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<author><name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name>
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<author><name sortKey="Csoti, Iiona" sort="Csoti, Iiona" uniqKey="Csoti I" first="Iiona" last="Csoti">Iiona Csoti</name>
</author>
<author><name sortKey="Storch, Alexander" sort="Storch, Alexander" uniqKey="Storch A" first="Alexander" last="Storch">Alexander Storch</name>
</author>
<author><name sortKey="Huber, Heiko" sort="Huber, Heiko" uniqKey="Huber H" first="Heiko" last="Huber">Heiko Huber</name>
</author>
<author><name sortKey="Morelli Anelo, Monica" sort="Morelli Anelo, Monica" uniqKey="Morelli Anelo M" first="Monica" last="Morelli-Canelo">Monica Morelli-Canelo</name>
</author>
<author><name sortKey="Stamelou, Maria" sort="Stamelou, Maria" uniqKey="Stamelou M" first="Maria" last="Stamelou">Maria Stamelou</name>
</author>
<author><name sortKey="Ries, Vincent" sort="Ries, Vincent" uniqKey="Ries V" first="Vincent" last="Ries">Vincent Ries</name>
</author>
<author><name sortKey="Wolz, Martin" sort="Wolz, Martin" uniqKey="Wolz M" first="Martin" last="Wolz">Martin Wolz</name>
</author>
<author><name sortKey="Schneider, Christine" sort="Schneider, Christine" uniqKey="Schneider C" first="Christine" last="Schneider">Christine Schneider</name>
</author>
<author><name sortKey="Di Paolo, Therese" sort="Di Paolo, Therese" uniqKey="Di Paolo T" first="Thérèse" last="Di Paolo">Thérèse Di Paolo</name>
</author>
<author><name sortKey="Gasparini, Fabrizio" sort="Gasparini, Fabrizio" uniqKey="Gasparini F" first="Fabrizio" last="Gasparini">Fabrizio Gasparini</name>
</author>
<author><name sortKey="Hariry, Sam" sort="Hariry, Sam" uniqKey="Hariry S" first="Sam" last="Hariry">Sam Hariry</name>
</author>
<author><name sortKey="Vandemeulebroecke, Marc" sort="Vandemeulebroecke, Marc" uniqKey="Vandemeulebroecke M" first="Marc" last="Vandemeulebroecke">Marc Vandemeulebroecke</name>
</author>
<author><name sortKey="Abi Aab, Walid" sort="Abi Aab, Walid" uniqKey="Abi Aab W" first="Walid" last="Abi-Saab">Walid Abi-Saab</name>
</author>
<author><name sortKey="Cooke, Katy" sort="Cooke, Katy" uniqKey="Cooke K" first="Katy" last="Cooke">Katy Cooke</name>
</author>
<author><name sortKey="Johns, Donald" sort="Johns, Donald" uniqKey="Johns D" first="Donald" last="Johns">Donald Johns</name>
</author>
<author><name sortKey="Gomez Ancilla, Baltazar" sort="Gomez Ancilla, Baltazar" uniqKey="Gomez Ancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
</author>
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<idno type="doi">10.1002/mds.23616</idno>
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<sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">AFQ056 treatment of levodopa‐induced dyskinesias: Results of 2 randomized controlled trials</title>
<author><name sortKey="Berg, Daniela" sort="Berg, Daniela" uniqKey="Berg D" first="Daniela" last="Berg">Daniela Berg</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Tübingen, Hertie‐Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Godau, Jana" sort="Godau, Jana" uniqKey="Godau J" first="Jana" last="Godau">Jana Godau</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Tübingen, Hertie‐Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name>
<affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Paracelsus‐Elena‐Klinik, Kassel, University of Goettingen</wicri:regionArea>
<wicri:noRegion>University of Goettingen</wicri:noRegion>
<wicri:noRegion>University of Goettingen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Phillipps‐University of 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>
<author><name sortKey="Csoti, Iiona" sort="Csoti, Iiona" uniqKey="Csoti I" first="Iiona" last="Csoti">Iiona Csoti</name>
<affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Gertrudis Klinik, Biskirchen</wicri:regionArea>
<wicri:noRegion>Biskirchen</wicri:noRegion>
<wicri:noRegion>Biskirchen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Storch, Alexander" sort="Storch, Alexander" uniqKey="Storch A" first="Alexander" last="Storch">Alexander Storch</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, Dresden University of Technology, Dresden</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Dresde</region>
<settlement type="city">Dresde</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Huber, Heiko" sort="Huber, Heiko" uniqKey="Huber H" first="Heiko" last="Huber">Heiko Huber</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Tübingen, Hertie‐Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Morelli Anelo, Monica" sort="Morelli Anelo, Monica" uniqKey="Morelli Anelo M" first="Monica" last="Morelli-Canelo">Monica Morelli-Canelo</name>
<affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Paracelsus‐Elena‐Klinik, Kassel, University of Goettingen</wicri:regionArea>
<wicri:noRegion>University of Goettingen</wicri:noRegion>
<wicri:noRegion>University of Goettingen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Stamelou, Maria" sort="Stamelou, Maria" uniqKey="Stamelou M" first="Maria" last="Stamelou">Maria Stamelou</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Phillipps‐University of 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>
<author><name sortKey="Ries, Vincent" sort="Ries, Vincent" uniqKey="Ries V" first="Vincent" last="Ries">Vincent Ries</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Phillipps‐University of 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>
<author><name sortKey="Wolz, Martin" sort="Wolz, Martin" uniqKey="Wolz M" first="Martin" last="Wolz">Martin Wolz</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, Dresden University of Technology, Dresden</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Dresde</region>
<settlement type="city">Dresde</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schneider, Christine" sort="Schneider, Christine" uniqKey="Schneider C" first="Christine" last="Schneider">Christine Schneider</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, Dresden University of Technology, Dresden</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Dresde</region>
<settlement type="city">Dresde</settlement>
</placeName>
</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>
<affiliation wicri:level="1"><country xml:lang="fr">Canada</country>
<wicri:regionArea>Molecular Endocrinology and Genomic Research Center, Laval University Medical Center, Québec, Canada and Faculty of Pharmacy, Laval University, Québec</wicri:regionArea>
<wicri:noRegion>Québec</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gasparini, Fabrizio" sort="Gasparini, Fabrizio" uniqKey="Gasparini F" first="Fabrizio" last="Gasparini">Fabrizio Gasparini</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Neuroscience Discovery, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hariry, Sam" sort="Hariry, Sam" uniqKey="Hariry S" first="Sam" last="Hariry">Sam Hariry</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Neuroscience Discovery, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Vandemeulebroecke, Marc" sort="Vandemeulebroecke, Marc" uniqKey="Vandemeulebroecke M" first="Marc" last="Vandemeulebroecke">Marc Vandemeulebroecke</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Translational Science Biostatistics, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Abi Aab, Walid" sort="Abi Aab, Walid" uniqKey="Abi Aab W" first="Walid" last="Abi-Saab">Walid Abi-Saab</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Neuroscience Discovery, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cooke, Katy" sort="Cooke, Katy" uniqKey="Cooke K" first="Katy" last="Cooke">Katy Cooke</name>
<affiliation wicri:level="1"><country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Alpha‐Plus Medical Communications Ltd., High Wycombe</wicri:regionArea>
<wicri:noRegion>High Wycombe</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Johns, Donald" sort="Johns, Donald" uniqKey="Johns D" first="Donald" last="Johns">Donald Johns</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Neuroscience Discovery, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gomez Ancilla, Baltazar" sort="Gomez Ancilla, Baltazar" uniqKey="Gomez Ancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>Neuroscience Discovery, Novartis Pharma AG, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</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="2011-06">2011-06</date>
<biblScope unit="vol">26</biblScope>
<biblScope unit="issue">7</biblScope>
<biblScope unit="page" from="1243">1243</biblScope>
<biblScope unit="page" to="1250">1250</biblScope>
</imprint>
<idno type="ISSN">0885-3185</idno>
</series>
<idno type="istex">2825E65A3F6F57FE798A88403A3D460C66614535</idno>
<idno type="DOI">10.1002/mds.23616</idno>
<idno type="ArticleID">MDS23616</idno>
</biblStruct>
</sourceDesc>
<seriesStmt><idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>dyskinesias</term>
<term>glutamate antagonists</term>
<term>levodopa</term>
<term>parkinsonism</term>
</keywords>
</textClass>
<langUsage><language ident="en">en</language>
</langUsage>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Study objectives were to assess the efficacy, safety, and tolerability of AFQ056 in Parkinson's disease patients with levodopa‐induced dyskinesia. Two randomized, double‐blind, placebo‐controlled, parallel‐group, in‐patient studies for Parkinson's disease patients with moderate to severe levodopa‐induced dyskinesia (study 1) and severe levodopa‐induced dyskinesia (study 2) on stable dopaminergic therapy were performed. Patients received 25–150 mg AFQ056 or placebo twice daily for 16 days (both studies). Study 2 included a 4‐day down‐titration. Primary outcomes were the Lang‐Fahn Activities of Daily Living Dyskinesia Scale (study 1), the modified Abnormal Involuntary Movement Scale (study 2), and the Unified Parkinson's Disease Rating Scale–part III (both studies). Secondary outcomes included the Unified Parkinson's Disease Rating Scale–part IV items 32–33. The primary analysis was change from baseline to day 16 on all outcomes. Treatment differences were assessed. Fifteen patients were randomized to AFQ056 and 16 to placebo in study 1; 14 patients were randomized to each group in study 2. AFQ056‐treated patients showed significant improvements in dyskinesias on day 16 versus placebo (eg, Lang‐Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1]; modified Abnormal Involuntary Movement Scale, P = .032 [study 2]). No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale‐part III in either study. Adverse events were reported in both studies, including dizziness. Serious adverse events (most commonly worsening of dyskinesias, apparently associated with stopping treatment) were reported by 4 AFQ056‐treated patients in study 1, and 3 patients (2 AFQ056‐treated patient and 1 in the placebo group) in study 2. AFQ056 showed a clinically relevant and significant antidyskinetic effect without changing the antiparkinsonian effects of dopaminergic therapy. © 2011 Movement Disorder Society</div>
</front>
</TEI>
</ISTEX>
<PubMed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials.</title>
<author><name sortKey="Berg, Daniela" sort="Berg, Daniela" uniqKey="Berg D" first="Daniela" last="Berg">Daniela Berg</name>
<affiliation wicri:level="3"><nlm:affiliation>University of Tübingen, Hertie-Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Tübingen, Hertie-Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Godau, Jana" sort="Godau, Jana" uniqKey="Godau J" first="Jana" last="Godau">Jana Godau</name>
</author>
<author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name>
</author>
<author><name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name>
</author>
<author><name sortKey="Csoti, Iiona" sort="Csoti, Iiona" uniqKey="Csoti I" first="Iiona" last="Csoti">Iiona Csoti</name>
</author>
<author><name sortKey="Storch, Alexander" sort="Storch, Alexander" uniqKey="Storch A" first="Alexander" last="Storch">Alexander Storch</name>
</author>
<author><name sortKey="Huber, Heiko" sort="Huber, Heiko" uniqKey="Huber H" first="Heiko" last="Huber">Heiko Huber</name>
</author>
<author><name sortKey="Morelli Canelo, Monica" sort="Morelli Canelo, Monica" uniqKey="Morelli Canelo M" first="Monica" last="Morelli-Canelo">Monica Morelli-Canelo</name>
</author>
<author><name sortKey="Stamelou, Maria" sort="Stamelou, Maria" uniqKey="Stamelou M" first="Maria" last="Stamelou">Maria Stamelou</name>
</author>
<author><name sortKey="Ries, Vincent" sort="Ries, Vincent" uniqKey="Ries V" first="Vincent" last="Ries">Vincent Ries</name>
</author>
<author><name sortKey="Wolz, Martin" sort="Wolz, Martin" uniqKey="Wolz M" first="Martin" last="Wolz">Martin Wolz</name>
</author>
<author><name sortKey="Schneider, Christine" sort="Schneider, Christine" uniqKey="Schneider C" first="Christine" last="Schneider">Christine Schneider</name>
</author>
<author><name sortKey="Di Paolo, Therese" sort="Di Paolo, Therese" uniqKey="Di Paolo T" first="Thérèse" last="Di Paolo">Thérèse Di Paolo</name>
</author>
<author><name sortKey="Gasparini, Fabrizio" sort="Gasparini, Fabrizio" uniqKey="Gasparini F" first="Fabrizio" last="Gasparini">Fabrizio Gasparini</name>
</author>
<author><name sortKey="Hariry, Sam" sort="Hariry, Sam" uniqKey="Hariry S" first="Sam" last="Hariry">Sam Hariry</name>
</author>
<author><name sortKey="Vandemeulebroecke, Marc" sort="Vandemeulebroecke, Marc" uniqKey="Vandemeulebroecke M" first="Marc" last="Vandemeulebroecke">Marc Vandemeulebroecke</name>
</author>
<author><name sortKey="Abi Saab, Walid" sort="Abi Saab, Walid" uniqKey="Abi Saab W" first="Walid" last="Abi-Saab">Walid Abi-Saab</name>
</author>
<author><name sortKey="Cooke, Katy" sort="Cooke, Katy" uniqKey="Cooke K" first="Katy" last="Cooke">Katy Cooke</name>
</author>
<author><name sortKey="Johns, Donald" sort="Johns, Donald" uniqKey="Johns D" first="Donald" last="Johns">Donald Johns</name>
</author>
<author><name sortKey="Gomez Mancilla, Baltazar" sort="Gomez Mancilla, Baltazar" uniqKey="Gomez Mancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
</author>
</titleStmt>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials.</title>
<author><name sortKey="Berg, Daniela" sort="Berg, Daniela" uniqKey="Berg D" first="Daniela" last="Berg">Daniela Berg</name>
<affiliation wicri:level="3"><nlm:affiliation>University of Tübingen, Hertie-Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Tübingen, Hertie-Institute of Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Godau, Jana" sort="Godau, Jana" uniqKey="Godau J" first="Jana" last="Godau">Jana Godau</name>
</author>
<author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name>
</author>
<author><name sortKey="Eggert, Karla" sort="Eggert, Karla" uniqKey="Eggert K" first="Karla" last="Eggert">Karla Eggert</name>
</author>
<author><name sortKey="Csoti, Iiona" sort="Csoti, Iiona" uniqKey="Csoti I" first="Iiona" last="Csoti">Iiona Csoti</name>
</author>
<author><name sortKey="Storch, Alexander" sort="Storch, Alexander" uniqKey="Storch A" first="Alexander" last="Storch">Alexander Storch</name>
</author>
<author><name sortKey="Huber, Heiko" sort="Huber, Heiko" uniqKey="Huber H" first="Heiko" last="Huber">Heiko Huber</name>
</author>
<author><name sortKey="Morelli Canelo, Monica" sort="Morelli Canelo, Monica" uniqKey="Morelli Canelo M" first="Monica" last="Morelli-Canelo">Monica Morelli-Canelo</name>
</author>
<author><name sortKey="Stamelou, Maria" sort="Stamelou, Maria" uniqKey="Stamelou M" first="Maria" last="Stamelou">Maria Stamelou</name>
</author>
<author><name sortKey="Ries, Vincent" sort="Ries, Vincent" uniqKey="Ries V" first="Vincent" last="Ries">Vincent Ries</name>
</author>
<author><name sortKey="Wolz, Martin" sort="Wolz, Martin" uniqKey="Wolz M" first="Martin" last="Wolz">Martin Wolz</name>
</author>
<author><name sortKey="Schneider, Christine" sort="Schneider, Christine" uniqKey="Schneider C" first="Christine" last="Schneider">Christine Schneider</name>
</author>
<author><name sortKey="Di Paolo, Therese" sort="Di Paolo, Therese" uniqKey="Di Paolo T" first="Thérèse" last="Di Paolo">Thérèse Di Paolo</name>
</author>
<author><name sortKey="Gasparini, Fabrizio" sort="Gasparini, Fabrizio" uniqKey="Gasparini F" first="Fabrizio" last="Gasparini">Fabrizio Gasparini</name>
</author>
<author><name sortKey="Hariry, Sam" sort="Hariry, Sam" uniqKey="Hariry S" first="Sam" last="Hariry">Sam Hariry</name>
</author>
<author><name sortKey="Vandemeulebroecke, Marc" sort="Vandemeulebroecke, Marc" uniqKey="Vandemeulebroecke M" first="Marc" last="Vandemeulebroecke">Marc Vandemeulebroecke</name>
</author>
<author><name sortKey="Abi Saab, Walid" sort="Abi Saab, Walid" uniqKey="Abi Saab W" first="Walid" last="Abi-Saab">Walid Abi-Saab</name>
</author>
<author><name sortKey="Cooke, Katy" sort="Cooke, Katy" uniqKey="Cooke K" first="Katy" last="Cooke">Katy Cooke</name>
</author>
<author><name sortKey="Johns, Donald" sort="Johns, Donald" uniqKey="Johns D" first="Donald" last="Johns">Donald Johns</name>
</author>
<author><name sortKey="Gomez Mancilla, Baltazar" sort="Gomez Mancilla, Baltazar" uniqKey="Gomez Mancilla B" first="Baltazar" last="Gomez-Mancilla">Baltazar Gomez-Mancilla</name>
</author>
</analytic>
<series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
<idno type="eISSN">1531-8257</idno>
<imprint><date when="2011" type="published">2011</date>
</imprint>
</series>
</biblStruct>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antiparkinson Agents (adverse effects)</term>
<term>Drug Interactions</term>
<term>Dyskinesia, Drug-Induced (drug therapy)</term>
<term>Excitatory Amino Acid Antagonists (administration & dosage)</term>
<term>Excitatory Amino Acid Antagonists (adverse effects)</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Levodopa (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Receptor, Metabotropic Glutamate 5</term>
<term>Receptors, Metabotropic Glutamate (antagonists & inhibitors)</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Excitatory Amino Acid Antagonists</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Excitatory Amino Acid Antagonists</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Receptors, Metabotropic Glutamate</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dyskinesia, Drug-Induced</term>
<term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Drug Interactions</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Receptor, Metabotropic Glutamate 5</term>
<term>Treatment Outcome</term>
</keywords>
</textClass>
</profileDesc>
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<front><div type="abstract" xml:lang="en">Study objectives were to assess the efficacy, safety, and tolerability of AFQ056 in Parkinson's disease patients with levodopa-induced dyskinesia. Two randomized, double-blind, placebo-controlled, parallel-group, in-patient studies for Parkinson's disease patients with moderate to severe levodopa-induced dyskinesia (study 1) and severe levodopa-induced dyskinesia (study 2) on stable dopaminergic therapy were performed. Patients received 25-150 mg AFQ056 or placebo twice daily for 16 days (both studies). Study 2 included a 4-day down-titration. Primary outcomes were the Lang-Fahn Activities of Daily Living Dyskinesia Scale (study 1), the modified Abnormal Involuntary Movement Scale (study 2), and the Unified Parkinson's Disease Rating Scale-part III (both studies). Secondary outcomes included the Unified Parkinson's Disease Rating Scale-part IV items 32-33. The primary analysis was change from baseline to day 16 on all outcomes. Treatment differences were assessed. Fifteen patients were randomized to AFQ056 and 16 to placebo in study 1; 14 patients were randomized to each group in study 2. AFQ056-treated patients showed significant improvements in dyskinesias on day 16 versus placebo (eg, Lang-Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1]; modified Abnormal Involuntary Movement Scale, P = .032 [study 2]). No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale-part III in either study. Adverse events were reported in both studies, including dizziness. Serious adverse events (most commonly worsening of dyskinesias, apparently associated with stopping treatment) were reported by 4 AFQ056-treated patients in study 1, and 3 patients (2 AFQ056-treated patient and 1 in the placebo group) in study 2. AFQ056 showed a clinically relevant and significant antidyskinetic effect without changing the antiparkinsonian effects of dopaminergic therapy. © 2011 Movement Disorder Society.</div>
</front>
</TEI>
</PubMed>
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