A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease
Identifieur interne : 001624 ( Main/Corpus ); précédent : 001623; suivant : 001625A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease
Auteurs : Jean-Louis Montastruc ; Marc Ziegler ; Olivier Rascol ; Muriel MalbezinSource :
- Movement Disorders [ 0885-3185 ] ; 1999-03.
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- KwdEn :
Abstract
This randomized, double‐blind trial was designed to evaluate the efficacy of a transdermal system of piribedil on the motor symptoms of Parkinson's disease during 3 weeks of treatment administered to three different groups: placebo, one piribedil patch (1 PP), and two (2 PP) piribedil patches. Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. These plasma levels could account for the lack of clinical efficacy, because a previous pharmacokinetics‐PD study conducted in parkinsonian patients and treated with the intravenous route demonstrated that the critical limits of activity on tremor were between 10 and 30 ng/mL.
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DOI: 10.1002/1531-8257(199903)14:2<336::AID-MDS1021>3.0.CO;2-9
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ISTEX:4265CEFE8BB9B36ABF97EF9B3CE6A2055BDB6E1DLe document en format XML
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Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. 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Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. 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Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. 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Twenty‐seven patients with idiopathic Parkinson's disease, treated with <sc>L</sc>‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. These plasma levels could account for the lack of clinical efficacy, because a previous pharmacokinetics‐PD study conducted in parkinsonian patients and treated with the intravenous route demonstrated that the critical limits of activity on tremor were between 10 and 30 ng/mL.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Skin Patch of a Dopaminergic Agonist in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>A randomized, double‐blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Jean‐Louis</namePart><namePart type="family">Montastruc</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Service de Pharmacologie Clinique, Faculté de Médecine, Hôpitaux de Toulouse, Toulouse, France</affiliation><description>Correspondence: Service de Pharmacologie Clinique, Faculté de Médecine, Hôpitaux de Toulouse, 37 allées Jules Guesde, 31073 Toulouse cedex, France</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marc</namePart><namePart type="family">Ziegler</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Unité James Parkinson, Hôpital Léopold Bellan, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Rascol</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Service de Pharmacologie Clinique, Faculté de Médecine, Hôpitaux de Toulouse, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Muriel</namePart><namePart type="family">Malbezin</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Centre d'Investigation Clinique (CIC) du Centre Hospitalier Universitaire de Toulouse, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="brief communication" displayLabel="shortCommunication"></genre><originInfo><publisher>John Wiley & Sons, Inc.</publisher><place><placeTerm type="text">New York</placeTerm></place><dateIssued encoding="w3cdtf">1999-03</dateIssued><dateCaptured encoding="w3cdtf">1998-03-13</dateCaptured><dateValid encoding="w3cdtf">1998-10-16</dateValid><copyrightDate encoding="w3cdtf">1999</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">1</extent><extent unit="tables">3</extent><extent unit="references">26</extent><extent unit="words">3132</extent></physicalDescription><abstract lang="en">This randomized, double‐blind trial was designed to evaluate the efficacy of a transdermal system of piribedil on the motor symptoms of Parkinson's disease during 3 weeks of treatment administered to three different groups: placebo, one piribedil patch (1 PP), and two (2 PP) piribedil patches. Twenty‐seven patients with idiopathic Parkinson's disease, treated with L‐dopa but not sufficiently controlled, were included in this trial. The test treatment did not demonstrate any clinical efficacy on either the main end point (Unified Parkinson's Disease Rating Scale motor score) or the secondary end points (rigidity, bradykinesia, postural, and resting tremor scores). The main adverse events were nausea (11%), vomiting (7.4%), and malaise (7.4%) mainly observed in the placebo group (four of seven patients). The local acceptability of the transdermal system was good. Plasma piribedil concentrations at the end of treatment were 6.74 ± 1.10 and 9.31 ± 3.33 ng/mL in the 1 PP and 2 PP groups, respectively. These plasma levels could account for the lack of clinical efficacy, because a previous pharmacokinetics‐PD study conducted in parkinsonian patients and treated with the intravenous route demonstrated that the critical limits of activity on tremor were between 10 and 30 ng/mL.</abstract><subject lang="en"><genre>Keywords</genre><topic>Piribedil</topic><topic>Parkinson's disease</topic><topic>Transdermal patch</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Brief Report</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>1999</date><detail type="volume"><caption>vol.</caption><number>14</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>336</start><end>341</end><total>6</total></extent></part></relatedItem><identifier type="istex">4265CEFE8BB9B36ABF97EF9B3CE6A2055BDB6E1D</identifier><identifier type="DOI">10.1002/1531-8257(199903)14:2<336::AID-MDS1021>3.0.CO;2-9</identifier><identifier type="ArticleID">MDS1021</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 1999 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>John Wiley & Sons, Inc.</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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