Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.
Identifieur interne : 003388 ( PubMed/Corpus ); précédent : 003387; suivant : 003389Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.
Auteurs : Matthew B. Stern ; Kenneth L. Marek ; Joseph Friedman ; Robert A. Hauser ; Peter A. Lewitt ; Daniel Tarsy ; C Warren OlanowSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2004.
English descriptors
- KwdEn :
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Indans (pharmacokinetics), Indans (therapeutic use), Male, Middle Aged, Monoamine Oxidase Inhibitors (pharmacokinetics), Monoamine Oxidase Inhibitors (therapeutic use), Multicenter Studies as Topic, Parkinson Disease (complications), Parkinson Disease (drug therapy), Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , pharmacokinetics : Indans, Monoamine Oxidase Inhibitors.
- chemical , therapeutic use : Indans, Monoamine Oxidase Inhibitors.
- complications : Parkinson Disease.
- drug therapy : Parkinson Disease.
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Multicenter Studies as Topic, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (+/-SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (+/-1.3), -3.6 (+/-1.7), -3.6 (+/-1.2), and -0.5 (+/-0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.
DOI: 10.1002/mds.20145
PubMed: 15300656
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.</title><author><name sortKey="Stern, Matthew B" sort="Stern, Matthew B" uniqKey="Stern M" first="Matthew B" last="Stern">Matthew B. Stern</name><affiliation><nlm:affiliation>University of Pennsylvania, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Marek, Kenneth L" sort="Marek, Kenneth L" uniqKey="Marek K" first="Kenneth L" last="Marek">Kenneth L. Marek</name></author><author><name sortKey="Friedman, Joseph" sort="Friedman, Joseph" uniqKey="Friedman J" first="Joseph" last="Friedman">Joseph Friedman</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A" last="Lewitt">Peter A. Lewitt</name></author><author><name sortKey="Tarsy, Daniel" sort="Tarsy, Daniel" uniqKey="Tarsy D" first="Daniel" last="Tarsy">Daniel Tarsy</name></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C Warren" last="Olanow">C Warren Olanow</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2004">2004</date><idno type="RBID">pubmed:15300656</idno><idno type="pmid">15300656</idno><idno type="doi">10.1002/mds.20145</idno><idno type="wicri:Area/PubMed/Corpus">003388</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.</title><author><name sortKey="Stern, Matthew B" sort="Stern, Matthew B" uniqKey="Stern M" first="Matthew B" last="Stern">Matthew B. Stern</name><affiliation><nlm:affiliation>University of Pennsylvania, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Marek, Kenneth L" sort="Marek, Kenneth L" uniqKey="Marek K" first="Kenneth L" last="Marek">Kenneth L. Marek</name></author><author><name sortKey="Friedman, Joseph" sort="Friedman, Joseph" uniqKey="Friedman J" first="Joseph" last="Friedman">Joseph Friedman</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Lewitt, Peter A" sort="Lewitt, Peter A" uniqKey="Lewitt P" first="Peter A" last="Lewitt">Peter A. Lewitt</name></author><author><name sortKey="Tarsy, Daniel" sort="Tarsy, Daniel" uniqKey="Tarsy D" first="Daniel" last="Tarsy">Daniel Tarsy</name></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C Warren" last="Olanow">C Warren Olanow</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2004" type="published">2004</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</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>Incidence</term><term>Indans (pharmacokinetics)</term><term>Indans (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Monoamine Oxidase Inhibitors (pharmacokinetics)</term><term>Monoamine Oxidase Inhibitors (therapeutic use)</term><term>Multicenter Studies as Topic</term><term>Parkinson Disease (complications)</term><term>Parkinson Disease (drug therapy)</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Indans</term><term>Monoamine Oxidase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Indans</term><term>Monoamine Oxidase Inhibitors</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</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>Incidence</term><term>Male</term><term>Middle Aged</term><term>Multicenter Studies as Topic</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (+/-SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (+/-1.3), -3.6 (+/-1.7), -3.6 (+/-1.2), and -0.5 (+/-0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">15300656</PMID><DateCreated><Year>2004</Year><Month>08</Month><Day>09</Day></DateCreated><DateCompleted><Year>2004</Year><Month>12</Month><Day>20</Day></DateCompleted><DateRevised><Year>2012</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>19</Volume><Issue>8</Issue><PubDate><Year>2004</Year><Month>Aug</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.</ArticleTitle><Pagination><MedlinePgn>916-23</MedlinePgn></Pagination><Abstract><AbstractText>Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (+/-SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (+/-1.3), -3.6 (+/-1.7), -3.6 (+/-1.2), and -0.5 (+/-0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.</AbstractText><CopyrightInformation>Copyright 2004 Movement Disorder Society</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Stern</LastName><ForeName>Matthew B</ForeName><Initials>MB</Initials><AffiliationInfo><Affiliation>University of Pennsylvania, Philadelphia, Pennsylvania, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marek</LastName><ForeName>Kenneth L</ForeName><Initials>KL</Initials></Author><Author ValidYN="Y"><LastName>Friedman</LastName><ForeName>Joseph</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials></Author><Author ValidYN="Y"><LastName>LeWitt</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials></Author><Author ValidYN="Y"><LastName>Tarsy</LastName><ForeName>Daniel</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Olanow</LastName><ForeName>C Warren</ForeName><Initials>CW</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></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="D007189">Indans</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008996">Monoamine Oxidase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>003N66TS6T</RegistryNumber><NameOfSubstance UI="C031967">rasagiline</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></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" 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Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000150">complications</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2004</Year><Month>8</Month><Day>10</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2004</Year><Month>12</Month><Day>21</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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