Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations
Identifieur interne : 000C63 ( Main/Exploration ); précédent : 000C62; suivant : 000C64Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations
Auteurs : Robert A. Hauser [États-Unis] ; Lisa M. Shulman [États-Unis] ; Joel M. Trugman [États-Unis] ; John W. Roberts [États-Unis] ; Akihisa Mori [Japon] ; Rocco Ballerini [États-Unis] ; Neil M. Sussman [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2008-11-15.
English descriptors
Abstract
The objective of this study was to evaluate the efficacy, safety, and tolerability of istradefylline 20 mg once daily versus placebo as an adjunct to levodopa in subjects with Parkinson's disease (PD) who have motor fluctuations. Istradefylline (KW‐6002) is an adenosine A2A receptor antagonist that in primate models of PD improves motor function without causing or worsening dyskinesia. This 12‐week, multicenter, double‐blind, placebo‐controlled, randomized, Phase 3 study of istradefylline was conducted in subjects experiencing an average daily OFF time of at least 3 hours (116 randomized to istradefylline; 115 to placebo). All were on stable levodopa regimens; 90% were also on stable regimens of other anti‐Parkinson's medications. Istradefylline‐treated subjects had significant placebo‐corrected reductions in daily OFF time from baseline to endpoint: 4.6% (P = 0.03) and 0.7 hours (P = 0.03). For ON time with troublesome dyskinesia, the changes between istradefylline and placebo were not significant. Istradefylline was well tolerated, with 6 (5.2%) istradefylline‐treated and 7 (6.1%) placebo‐treated subjects withdrawing from the study because of adverse events. Dyskinesia, lightheadedness, tremor, constipation, and weight decrease were reported more often with istradefylline than placebo. We conclude that istradefylline is well tolerated and significantly reduces OFF time as an adjunct to levodopa in PD subjects with motor fluctuations. © 2008 Movement Disorder Society
Url:
DOI: 10.1002/mds.22095
Affiliations:
- Japon, États-Unis
- Floride, Maryland, New Jersey, Virginie, Washington (État)
- Tampa
- Université de Floride du Sud
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations</title><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="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M." last="Shulman">Lisa M. Shulman</name></author><author><name sortKey="Trugman, Joel M" sort="Trugman, Joel M" uniqKey="Trugman J" first="Joel M." last="Trugman">Joel M. Trugman</name></author><author><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W." last="Roberts">John W. Roberts</name></author><author><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name></author><author><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name></author><author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M." last="Sussman">Neil M. Sussman</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4</idno><date when="2008" year="2008">2008</date><idno type="doi">10.1002/mds.22095</idno><idno type="url">https://api.istex.fr/document/D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">001C54</idno><idno type="wicri:Area/Main/Curation">001982</idno><idno type="wicri:Area/Main/Exploration">000C63</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology, Molecular Pharmacology, and Physiology, 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="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M." last="Shulman">Lisa M. Shulman</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Maryland School of Medicine, Baltimore, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Trugman, Joel M" sort="Trugman, Joel M" uniqKey="Trugman J" first="Joel M." last="Trugman">Joel M. Trugman</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Virginia, Charlottesville, Virginia</wicri:regionArea><placeName><region type="state">Virginie</region></placeName></affiliation></author><author><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W." last="Roberts">John W. Roberts</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Section of Neurology, Virginia Mason Medical Center, Seattle, Washington</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name><affiliation wicri:level="1"><country xml:lang="fr">Japon</country><wicri:regionArea>Kyowa Hakko Kogyo Co., Ltd. Tokyo</wicri:regionArea><wicri:noRegion>Ltd. Tokyo</wicri:noRegion></affiliation></author><author><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Kyowa Pharmaceutical, Inc., Princeton, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M." last="Sussman">Neil M. Sussman</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Kyowa Pharmaceutical, Inc., Princeton, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. 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="2008-11-15">2008-11-15</date><biblScope unit="volume">23</biblScope><biblScope unit="issue">15</biblScope><biblScope unit="page" from="2177">2177</biblScope><biblScope unit="page" to="2185">2185</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4</idno><idno type="DOI">10.1002/mds.22095</idno><idno type="ArticleID">MDS22095</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>KW‐6002</term><term>Parkinson's disease</term><term>istradefylline</term><term>motor fluctuations</term><term>off time</term><term>treatment</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to evaluate the efficacy, safety, and tolerability of istradefylline 20 mg once daily versus placebo as an adjunct to levodopa in subjects with Parkinson's disease (PD) who have motor fluctuations. Istradefylline (KW‐6002) is an adenosine A2A receptor antagonist that in primate models of PD improves motor function without causing or worsening dyskinesia. This 12‐week, multicenter, double‐blind, placebo‐controlled, randomized, Phase 3 study of istradefylline was conducted in subjects experiencing an average daily OFF time of at least 3 hours (116 randomized to istradefylline; 115 to placebo). All were on stable levodopa regimens; 90% were also on stable regimens of other anti‐Parkinson's medications. Istradefylline‐treated subjects had significant placebo‐corrected reductions in daily OFF time from baseline to endpoint: 4.6% (P = 0.03) and 0.7 hours (P = 0.03). For ON time with troublesome dyskinesia, the changes between istradefylline and placebo were not significant. Istradefylline was well tolerated, with 6 (5.2%) istradefylline‐treated and 7 (6.1%) placebo‐treated subjects withdrawing from the study because of adverse events. Dyskinesia, lightheadedness, tremor, constipation, and weight decrease were reported more often with istradefylline than placebo. We conclude that istradefylline is well tolerated and significantly reduces OFF time as an adjunct to levodopa in PD subjects with motor fluctuations. © 2008 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Japon</li><li>États-Unis</li></country><region><li>Floride</li><li>Maryland</li><li>New Jersey</li><li>Virginie</li><li>Washington (État)</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><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><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W." last="Roberts">John W. Roberts</name><name sortKey="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M." last="Shulman">Lisa M. Shulman</name><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M." last="Sussman">Neil M. Sussman</name><name sortKey="Trugman, Joel M" sort="Trugman, Joel M" uniqKey="Trugman J" first="Joel M." last="Trugman">Joel M. Trugman</name></country><country name="Japon"><noRegion><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/ParkinsonV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000C63 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000C63 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= ParkinsonV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4
|texte= Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations
}}
| This area was generated with Dilib version V0.6.23. |  |