Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease
Identifieur interne : 000057 ( France/Analysis ); précédent : 000056; suivant : 000058Double‐blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease
Auteurs : Juliana Bronzova [Pays-Bas] ; Cristina Sampaio [Portugal] ; Robert A. Hauser [États-Unis] ; Anthony E. Lang [Canada] ; Olivier Rascol [France] ; Ad Theeuwes [Pays-Bas] ; Serge V. Van De Witte [Pays-Bas] ; Guus Van Scharrenburg [Pays-Bas]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-04-30.
English descriptors
- KwdEn :
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 (≥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 ≥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. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.22948
Affiliations:
- Canada, France, Pays-Bas, Portugal, États-Unis
- Floride, Midi-Pyrénées, Ontario
- Tampa, Toronto, Toulouse
- Université Toulouse III - Paul Sabatier, Université de Floride du Sud, Université de Toronto, Université de Toulouse
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ISTEX:0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895Le document en format XML
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Lang</name></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><country>France</country><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></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. 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Hauser</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida, Tampa, Florida</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. 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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="2010-04-30">2010-04-30</date><biblScope unit="volume">25</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="738">738</biblScope><biblScope unit="page" to="746">746</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">0818D0A3C93DD11E6F3ADC2E1A7E86F9C5BFF895</idno><idno type="DOI">10.1002/mds.22948</idno><idno type="ArticleID">MDS22948</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>monotherapy</term><term>pardoprunox</term><term>partial dopamine agonist</term><term>randomized controlled clinical trial</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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 (≥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 ≥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. © 2010 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Canada</li><li>France</li><li>Pays-Bas</li><li>Portugal</li><li>États-Unis</li></country><region><li>Floride</li><li>Midi-Pyrénées</li><li>Ontario</li></region><settlement><li>Tampa</li><li>Toronto</li><li>Toulouse</li></settlement><orgName><li>Université Toulouse III - Paul Sabatier</li><li>Université de Floride du Sud</li><li>Université de Toronto</li><li>Université de Toulouse</li></orgName></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Bronzova, Juliana" sort="Bronzova, Juliana" uniqKey="Bronzova J" first="Juliana" last="Bronzova">Juliana Bronzova</name></noRegion><name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name><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><name sortKey="Van Scharrenburg, Guus" sort="Van Scharrenburg, Guus" uniqKey="Van Scharrenburg G" first="Guus" last="Van Scharrenburg">Guus Van Scharrenburg</name></country><country name="Portugal"><noRegion><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</name></noRegion></country><country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name></region></country><country name="Canada"><region name="Ontario"><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name></region></country><country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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