Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.
Identifieur interne : 001917 ( PubMed/Curation ); précédent : 001916; suivant : 001918Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.
Auteurs : Juliana Bronzova [Pays-Bas] ; Cristina Sampaio ; Robert A. Hauser ; Anthony E. Lang ; Olivier Rascol ; Ad Theeuwes ; Serge V. Van De Witte ; Guus Van ScharrenburgSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2010.
English descriptors
- KwdEn :
- Aged, Benzoxazoles (therapeutic use), Dopamine Agonists (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Parkinsonian Disorders (drug therapy), Piperazines (therapeutic use), Severity of Illness Index, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Benzoxazoles, Dopamine Agonists, Piperazines.
- drug therapy : Parkinsonian Disorders.
- Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome.
Abstract
This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (> or = 30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by > or = 10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.
DOI: 10.1002/mds.22948
PubMed: 20198713
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.</title><author><name sortKey="Bronzova, Juliana" sort="Bronzova, Juliana" uniqKey="Bronzova J" first="Juliana" last="Bronzova">Juliana Bronzova</name><affiliation wicri:level="1"><nlm:affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands. Juliana.Bronzova@solvay.com</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp</wicri:regionArea></affiliation></author><author><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</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="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name></author><author><name sortKey="Van De Witte, Serge V" sort="Van De Witte, Serge V" uniqKey="Van De Witte S" first="Serge V" last="Van De Witte">Serge V. Van De Witte</name></author><author><name sortKey="Van Scharrenburg, Guus" sort="Van Scharrenburg, Guus" uniqKey="Van Scharrenburg G" first="Guus" last="Van Scharrenburg">Guus Van Scharrenburg</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="doi">10.1002/mds.22948</idno><idno type="RBID">pubmed:20198713</idno><idno type="pmid">20198713</idno><idno type="wicri:Area/PubMed/Corpus">001917</idno><idno type="wicri:Area/PubMed/Curation">001917</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.</title><author><name sortKey="Bronzova, Juliana" sort="Bronzova, Juliana" uniqKey="Bronzova J" first="Juliana" last="Bronzova">Juliana Bronzova</name><affiliation wicri:level="1"><nlm:affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands. Juliana.Bronzova@solvay.com</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp</wicri:regionArea></affiliation></author><author><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</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="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name></author><author><name sortKey="Van De Witte, Serge V" sort="Van De Witte, Serge V" uniqKey="Van De Witte S" first="Serge V" last="Van De Witte">Serge V. Van De Witte</name></author><author><name sortKey="Van Scharrenburg, Guus" sort="Van Scharrenburg, Guus" uniqKey="Van Scharrenburg G" first="Guus" last="Van Scharrenburg">Guus Van Scharrenburg</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="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Benzoxazoles (therapeutic use)</term><term>Dopamine Agonists (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Parkinsonian Disorders (drug therapy)</term><term>Piperazines (therapeutic use)</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Benzoxazoles</term><term>Dopamine Agonists</term><term>Piperazines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinsonian Disorders</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (> or = 30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by > or = 10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">20198713</PMID><DateCreated><Year>2010</Year><Month>05</Month><Day>03</Day></DateCreated><DateCompleted><Year>2010</Year><Month>07</Month><Day>28</Day></DateCompleted><DateRevised><Year>2012</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>25</Volume><Issue>6</Issue><PubDate><Year>2010</Year><Month>Apr</Month><Day>30</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>738-46</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.22948</ELocationID><Abstract><AbstractText>This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (> or = 30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by > or = 10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.</AbstractText><CopyrightInformation>2010 Movement Disorder Society</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Bronzova</LastName><ForeName>Juliana</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department, Weesp, The Netherlands. 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UI="D017427">Clinical Trial, Phase II</PublicationType><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></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="D001583">Benzoxazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018491">Dopamine Agonists</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010879">Piperazines</NameOfSubstance></Chemical><Chemical><RegistryNumber>5R72CHP32S</RegistryNumber><NameOfSubstance 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ValidYN="Y"><LastName>Moskovko</LastName><ForeName>S</ForeName><Initials>S</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2010</Year><Month>3</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2010</Year><Month>3</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2010</Year><Month>7</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.22948</ArticleId><ArticleId IdType="pubmed">20198713</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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