Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations.
Identifieur interne : 000661 ( PubMed/Curation ); précédent : 000660; suivant : 000662Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations.
Auteurs : Rupam Borgohain [Inde] ; J. Szasz ; P. Stanzione ; C. Meshram ; M. Bhatt ; D. Chirilineau ; F. Stocchi ; V. Lucini ; R. Giuliani ; E. Forrest ; P. Rice ; R. AnandSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.
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 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.
DOI: 10.1002/mds.25751
PubMed: 24323641
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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></imprint></series></biblStruct></sourceDesc></fileDesc><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></keywords></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">24323641</PMID><DateCreated><Year>2014</Year><Month>03</Month><Day>04</Day></DateCreated><DateCompleted><Year>2014</Year><Month>10</Month><Day>29</Day></DateCompleted><DateRevised><Year>2015</Year><Month>01</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>29</Volume><Issue>2</Issue><PubDate><Year>2014</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations.</ArticleTitle><Pagination><MedlinePgn>229-37</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.25751</ELocationID><Abstract><AbstractText>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.</AbstractText><CopyrightInformation>© 2013 The Authors. Movement Disorders published by Wiley on behalf of the International Parkinson and Movement Disorder Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Borgohain</LastName><ForeName>Rupam</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Nizam's Institute of Medical Sciences, Hyderabad, India.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Szasz</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Stanzione</LastName><ForeName>P</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Meshram</LastName><ForeName>C</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Bhatt</LastName><ForeName>M</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Chirilineau</LastName><ForeName>D</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Stocchi</LastName><ForeName>F</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Lucini</LastName><ForeName>V</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Giuliani</LastName><ForeName>R</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Forrest</LastName><ForeName>E</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Rice</LastName><ForeName>P</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Anand</LastName><ForeName>R</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><CollectiveName>Study 016 Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>12</Month><Day>09</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001596">Benzylamines</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical><Chemical><RegistryNumber>90ENL74SIG</RegistryNumber><NameOfSubstance UI="C092797">safinamide</NameOfSubstance></Chemical><Chemical><RegistryNumber>OF5P57N2ZX</RegistryNumber><NameOfSubstance UI="D000409">Alanine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Neurotox Res. 2003;5(1-2):139-46</RefSource><PMID Version="1">12832228</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Neuropharmacol. 2000 Mar-Apr;23(2):75-81</RefSource><PMID Version="1">10803796</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Parkinsonism Relat Disord. 2013 May;19(5):508-14</RefSource><PMID Version="1">23402994</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Neurology. 2004 Aug 24;63(4):746-8</RefSource><PMID Version="1">15326260</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 1994 Jul;9(4):390-4</RefSource><PMID 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UI="D000409">Alanine</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000031">analogs & derivatives</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000978">Antiparkinson Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001596">Benzylamines</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007980">Levodopa</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009043">Motor Activity</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000528">radiation effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000503">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4285943</OtherID><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">MAO-B inhibitor</Keyword><Keyword MajorTopicYN="N">dyskinesia</Keyword><Keyword MajorTopicYN="N">safinamide</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Sahadulla</LastName><ForeName>M Illiyas</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kardan</LastName><ForeName>U</ForeName><Initials>U</Initials></Investigator><Investigator ValidYN="Y"><LastName>Keshava</LastName><ForeName>B S</ForeName><Initials>BS</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kishore</LastName><ForeName>A</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kothari</LastName><ForeName>S S</ForeName><Initials>SS</Initials></Investigator><Investigator ValidYN="Y"><LastName>Krishna Murthy</LastName><ForeName>J M</ForeName><Initials>JM</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kumar</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pal</LastName><ForeName>P Kumar</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mehta</LastName><ForeName>N</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Meshram</LastName><ForeName>C</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Prabhakar</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Prabhakar</LastName><ForeName>S Kr</ForeName><Initials>SK</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pradhan</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator><Investigator 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