Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations
Identifieur interne : 003E36 ( Ncbi/Merge ); précédent : 003E35; suivant : 003E37Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations
Auteurs : Rupam Borgohain [Inde] ; J. Szasz [Roumanie] ; P. Stanzione [Italie] ; C. Meshram [Inde] ; M. Bhatt [Inde] ; D. Chirilineau [Roumanie] ; F. Stocchi [Italie] ; V. Lucini [Italie] ; R. Giuliani [Italie] ; E. Forrest [Italie] ; P. Rice [États-Unis] ; R. Anand [Suisse]Source :
- Movement Disorders [ 0885-3185 ] ; 2013.
English descriptors
- KwdEn :
- Activities of Daily Living, Aged, Alanine (analogs & derivatives), Alanine (therapeutic use), Antiparkinson Agents (therapeutic use), Benzylamines (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Levodopa (therapeutic use), Male, Middle Aged, Motor Activity (drug effects), Motor Activity (radiation effects), Parkinson Disease (drug therapy), Parkinson Disease (physiopathology), Severity of Illness Index.
- MESH :
- chemical , analogs & derivatives : Alanine.
- chemical , therapeutic use : Alanine, Antiparkinson Agents, Benzylamines, Levodopa.
- drug effects : Motor Activity.
- drug therapy : Parkinson Disease.
- physiopathology : Parkinson Disease.
- radiation effects : Motor Activity.
- Activities of Daily Living, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Severity of Illness Index.
Abstract
Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to
Url:
DOI: 10.1002/mds.25751
PubMed: 24323641
PubMed Central: 4285943
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PMC:4285943Le document en format XML
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<series><title level="j">Movement Disorders</title>
<idno type="ISSN">0885-3185</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Activities of Daily Living</term>
<term>Aged</term>
<term>Alanine (analogs & derivatives)</term>
<term>Alanine (therapeutic use)</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Benzylamines (therapeutic use)</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Levodopa (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Motor Activity (drug effects)</term>
<term>Motor Activity (radiation effects)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson Disease (physiopathology)</term>
<term>Severity of Illness Index</term>
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<keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Alanine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Alanine</term>
<term>Antiparkinson Agents</term>
<term>Benzylamines</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Motor Activity</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="radiation effects" xml:lang="en"><term>Motor Activity</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Activities of Daily Living</term>
<term>Aged</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
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<front><div type="abstract" xml:lang="en"><p>Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to <sc>l</sc>
-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total <italic>on</italic>
time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included <italic>off</italic>
time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total <italic>on</italic>
time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in <italic>off</italic>
time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to <sc>l</sc>
-dopa in patients with PD and motor fluctuations significantly increased total <italic>on</italic>
time with no or nontroublesome dyskinesia, decreased <italic>off</italic>
time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.</p>
</div>
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<country xml:lang="fr">Roumanie</country>
<wicri:regionArea>Targu Mures</wicri:regionArea>
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<author><name sortKey="Stanzione, P" sort="Stanzione, P" uniqKey="Stanzione P" first="P" last="Stanzione">P. Stanzione</name>
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</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Roma</wicri:regionArea>
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</nlm:aff>
<country xml:lang="fr">Inde</country>
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<country xml:lang="fr">Inde</country>
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</author>
<author><name sortKey="Chirilineau, D" sort="Chirilineau, D" uniqKey="Chirilineau D" first="D" last="Chirilineau">D. Chirilineau</name>
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<country xml:lang="fr">Roumanie</country>
<wicri:regionArea>Timis</wicri:regionArea>
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<author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F" last="Stocchi">F. Stocchi</name>
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<country xml:lang="fr">Italie</country>
<wicri:regionArea>Rome</wicri:regionArea>
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<author><name sortKey="Lucini, V" sort="Lucini, V" uniqKey="Lucini V" first="V" last="Lucini">V. Lucini</name>
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<author><name sortKey="Giuliani, R" sort="Giuliani, R" uniqKey="Giuliani R" first="R" last="Giuliani">R. Giuliani</name>
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</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>SpA, Bresso</wicri:regionArea>
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<author><name sortKey="Rice, P" sort="Rice, P" uniqKey="Rice P" first="P" last="Rice">P. Rice</name>
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<addr-line>Naperville, Illinois, USA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Naperville, Illinois</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Anand, R" sort="Anand, R" uniqKey="Anand R" first="R" last="Anand">R. Anand</name>
<affiliation wicri:level="1"><nlm:aff id="au10"><institution>APC AG</institution>
<addr-line>St. Moritz, Switzerland</addr-line>
</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>St. Moritz</wicri:regionArea>
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<idno type="doi">10.1002/mds.25751</idno>
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<idno type="wicri:Area/Pmc/Corpus">000434</idno>
<idno type="wicri:Area/Pmc/Curation">000434</idno>
<idno type="wicri:Area/Pmc/Checkpoint">000079</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations</title>
<author><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name>
<affiliation wicri:level="1"><nlm:aff id="au1"><institution>Nizam's Institute of Medical Sciences</institution>
<addr-line>Hyderabad, India</addr-line>
</nlm:aff>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Hyderabad</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Szasz, J" sort="Szasz, J" uniqKey="Szasz J" first="J" last="Szasz">J. Szasz</name>
<affiliation wicri:level="1"><nlm:aff id="au2"><institution>Emergency Clinical County Hospital Targu Mures, University of Medicine and Pharmacy</institution>
<addr-line>Targu Mures, Romania</addr-line>
</nlm:aff>
<country xml:lang="fr">Roumanie</country>
<wicri:regionArea>Targu Mures</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Stanzione, P" sort="Stanzione, P" uniqKey="Stanzione P" first="P" last="Stanzione">P. Stanzione</name>
<affiliation wicri:level="1"><nlm:aff id="au3"><institution>Clinica Neurologica Università di Roma Tor Vergata and IRCCS Fondazione S Lucia</institution>
<addr-line>Roma, Italy</addr-line>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Roma</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Meshram, C" sort="Meshram, C" uniqKey="Meshram C" first="C" last="Meshram">C. Meshram</name>
<affiliation wicri:level="1"><nlm:aff id="au4"><institution>Brain and Mind Institute</institution>
<addr-line>Nagpur, India</addr-line>
</nlm:aff>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Nagpur</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bhatt, M" sort="Bhatt, M" uniqKey="Bhatt M" first="M" last="Bhatt">M. Bhatt</name>
<affiliation wicri:level="1"><nlm:aff id="au5"><institution>Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute</institution>
<addr-line>Mumbai, India</addr-line>
</nlm:aff>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Mumbai</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Chirilineau, D" sort="Chirilineau, D" uniqKey="Chirilineau D" first="D" last="Chirilineau">D. Chirilineau</name>
<affiliation wicri:level="1"><nlm:aff id="au6"><institution>University of Medicine and Pharmacy V Babes Timisoara, Emergency Clinic Hospital</institution>
<addr-line>Timis, Romania</addr-line>
</nlm:aff>
<country xml:lang="fr">Roumanie</country>
<wicri:regionArea>Timis</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F" last="Stocchi">F. Stocchi</name>
<affiliation wicri:level="1"><nlm:aff id="au7"><institution>IRCCS San Raffaele</institution>
<addr-line>Rome, Italy</addr-line>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Rome</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Lucini, V" sort="Lucini, V" uniqKey="Lucini V" first="V" last="Lucini">V. Lucini</name>
<affiliation wicri:level="1"><nlm:aff id="au8"><institution>Newron Pharmaceuticals</institution>
<addr-line>SpA, Bresso, Italy</addr-line>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>SpA, Bresso</wicri:regionArea>
<wicri:noRegion>Bresso</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Giuliani, R" sort="Giuliani, R" uniqKey="Giuliani R" first="R" last="Giuliani">R. Giuliani</name>
<affiliation wicri:level="1"><nlm:aff id="au8"><institution>Newron Pharmaceuticals</institution>
<addr-line>SpA, Bresso, Italy</addr-line>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>SpA, Bresso</wicri:regionArea>
<wicri:noRegion>Bresso</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Forrest, E" sort="Forrest, E" uniqKey="Forrest E" first="E" last="Forrest">E. Forrest</name>
<affiliation wicri:level="1"><nlm:aff id="au8"><institution>Newron Pharmaceuticals</institution>
<addr-line>SpA, Bresso, Italy</addr-line>
</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>SpA, Bresso</wicri:regionArea>
<wicri:noRegion>Bresso</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rice, P" sort="Rice, P" uniqKey="Rice P" first="P" last="Rice">P. Rice</name>
<affiliation wicri:level="2"><nlm:aff id="au9"><institution>Premier Research</institution>
<addr-line>Naperville, Illinois, USA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Naperville, Illinois</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Anand, R" sort="Anand, R" uniqKey="Anand R" first="R" last="Anand">R. Anand</name>
<affiliation wicri:level="1"><nlm:aff id="au10"><institution>APC AG</institution>
<addr-line>St. Moritz, Switzerland</addr-line>
</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>St. Moritz</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Movement Disorders</title>
<idno type="ISSN">0885-3185</idno>
<idno type="eISSN">1531-8257</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
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<profileDesc><textClass></textClass>
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<front><div type="abstract" xml:lang="en"><p>Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to <sc>l</sc>
-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total <italic>on</italic>
time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included <italic>off</italic>
time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total <italic>on</italic>
time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in <italic>off</italic>
time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to <sc>l</sc>
-dopa in patients with PD and motor fluctuations significantly increased total <italic>on</italic>
time with no or nontroublesome dyskinesia, decreased <italic>off</italic>
time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.</p>
</div>
</front>
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<pubmed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations.</title>
<author><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name>
<affiliation wicri:level="1"><nlm:affiliation>Nizam's Institute of Medical Sciences, Hyderabad, India.</nlm:affiliation>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Nizam's Institute of Medical Sciences, Hyderabad</wicri:regionArea>
<wicri:noRegion>Hyderabad</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Szasz, J" sort="Szasz, J" uniqKey="Szasz J" first="J" last="Szasz">J. Szasz</name>
</author>
<author><name sortKey="Stanzione, P" sort="Stanzione, P" uniqKey="Stanzione P" first="P" last="Stanzione">P. Stanzione</name>
</author>
<author><name sortKey="Meshram, C" sort="Meshram, C" uniqKey="Meshram C" first="C" last="Meshram">C. Meshram</name>
</author>
<author><name sortKey="Bhatt, M" sort="Bhatt, M" uniqKey="Bhatt M" first="M" last="Bhatt">M. Bhatt</name>
</author>
<author><name sortKey="Chirilineau, D" sort="Chirilineau, D" uniqKey="Chirilineau D" first="D" last="Chirilineau">D. Chirilineau</name>
</author>
<author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F" last="Stocchi">F. Stocchi</name>
</author>
<author><name sortKey="Lucini, V" sort="Lucini, V" uniqKey="Lucini V" first="V" last="Lucini">V. Lucini</name>
</author>
<author><name sortKey="Giuliani, R" sort="Giuliani, R" uniqKey="Giuliani R" first="R" last="Giuliani">R. Giuliani</name>
</author>
<author><name sortKey="Forrest, E" sort="Forrest, E" uniqKey="Forrest E" first="E" last="Forrest">E. Forrest</name>
</author>
<author><name sortKey="Rice, P" sort="Rice, P" uniqKey="Rice P" first="P" last="Rice">P. Rice</name>
</author>
<author><name sortKey="Anand, R" sort="Anand, R" uniqKey="Anand R" first="R" last="Anand">R. Anand</name>
</author>
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<idno type="doi">10.1002/mds.25751</idno>
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<idno type="wicri:Area/PubMed/Curation">000661</idno>
<idno type="wicri:Area/PubMed/Checkpoint">000456</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations.</title>
<author><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name>
<affiliation wicri:level="1"><nlm:affiliation>Nizam's Institute of Medical Sciences, Hyderabad, India.</nlm:affiliation>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Nizam's Institute of Medical Sciences, Hyderabad</wicri:regionArea>
<wicri:noRegion>Hyderabad</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Szasz, J" sort="Szasz, J" uniqKey="Szasz J" first="J" last="Szasz">J. Szasz</name>
</author>
<author><name sortKey="Stanzione, P" sort="Stanzione, P" uniqKey="Stanzione P" first="P" last="Stanzione">P. Stanzione</name>
</author>
<author><name sortKey="Meshram, C" sort="Meshram, C" uniqKey="Meshram C" first="C" last="Meshram">C. Meshram</name>
</author>
<author><name sortKey="Bhatt, M" sort="Bhatt, M" uniqKey="Bhatt M" first="M" last="Bhatt">M. Bhatt</name>
</author>
<author><name sortKey="Chirilineau, D" sort="Chirilineau, D" uniqKey="Chirilineau D" first="D" last="Chirilineau">D. Chirilineau</name>
</author>
<author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F" last="Stocchi">F. Stocchi</name>
</author>
<author><name sortKey="Lucini, V" sort="Lucini, V" uniqKey="Lucini V" first="V" last="Lucini">V. Lucini</name>
</author>
<author><name sortKey="Giuliani, R" sort="Giuliani, R" uniqKey="Giuliani R" first="R" last="Giuliani">R. Giuliani</name>
</author>
<author><name sortKey="Forrest, E" sort="Forrest, E" uniqKey="Forrest E" first="E" last="Forrest">E. Forrest</name>
</author>
<author><name sortKey="Rice, P" sort="Rice, P" uniqKey="Rice P" first="P" last="Rice">P. Rice</name>
</author>
<author><name sortKey="Anand, R" sort="Anand, R" uniqKey="Anand R" first="R" last="Anand">R. Anand</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="2014" type="published">2014</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Activities of Daily Living</term>
<term>Aged</term>
<term>Alanine (analogs & derivatives)</term>
<term>Alanine (therapeutic use)</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Benzylamines (therapeutic use)</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Levodopa (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Motor Activity (drug effects)</term>
<term>Motor Activity (radiation effects)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson Disease (physiopathology)</term>
<term>Severity of Illness Index</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Alanine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Alanine</term>
<term>Antiparkinson Agents</term>
<term>Benzylamines</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Motor Activity</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="radiation effects" xml:lang="en"><term>Motor Activity</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Activities of Daily Living</term>
<term>Aged</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Severity of Illness Index</term>
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<front><div type="abstract" xml:lang="en">Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.</div>
</front>
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