A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease
Identifieur interne : 002420 ( Main/Curation ); précédent : 002419; suivant : 002421A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease
Auteurs : M. Stacy [États-Unis] ; D. Silver [États-Unis] ; T. Mendis [Canada] ; J. Sutton [États-Unis] ; A. Mori [États-Unis] ; P. Chaikin [États-Unis] ; N. M. Sussman [États-Unis]Source :
- Neurology [ 0028-3878 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
Abstract
Background: The safety and efficacy of istradefylline, a selective adenosine A2A receptor antagonist, was evaluated in a 12-week, double-blind study in levodopa-treated Parkinson disease (PD) subjects with motor complications. Methods: Levodopa-treated PD subjects (n = 395) received istradefylline 20 mg/day (n = 163), istradefylline 60 mg/day (n = 155), or placebo (n = 77) at 40 sites. The primary efficacy variable was the change in the percentage of time per day spent in the OFF state. Secondary measurements assessed change in ON time, Unified Parkinson's Disease Rating Scale, and Clinical Global Impression. Safety monitoring included clinical laboratory, electrocardiograms, vital signs, physical/neurologic examinations, and adverse events (AEs). Results: Changes from baseline to endpoint in the percentage OFF time in the active groups compared with placebo were -4.35% (95% Cl -8.16 to -0.54; p = 0.026) for istradefylline 20 mg/day and -4.49% (95% Cl -8.35 to -0.62; p = 0.024) for 60 mg/day; these changes were significant (analysis of covariance). For total hours, istradefylline demonstrated mean differences from placebo of -0.64 hours (95% Cl -1.30 to 0.01) for 20 mg/day and -0.77 hours (95% Cl -1.44 to -0.11) for 60 mg/day (p = 0.065; overall treatment effect). Clinical response occurred by the second week and was maintained throughout the study. Istradefylline was well tolerated. The common AEs were dyskinesia, nausea, dizziness, and hallucinations. Conclusions: Istradefylline demonstrated a significant reduction in the percentage of awake time per day spent in the OFF state, which resulted in a clinically meaningful reduction in OFF time, without an increase in ON time with troublesome dyskinesia, and was well tolerated as adjunctive treatment to levodopa in Parkinson disease.
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: Pour aller vers cette notice dans l'étape Curation :000641
- to stream PascalFrancis, to step Curation: Pour aller vers cette notice dans l'étape Curation :000669
- to stream PascalFrancis, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :000575
- to stream Main, to step Merge: Pour aller vers cette notice dans l'étape Curation :002636
Links to Exploration step
Pascal:08-0298557Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease</title>
<author><name sortKey="Stacy, M" sort="Stacy, M" uniqKey="Stacy M" first="M." last="Stacy">M. Stacy</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Division of Neurology Duke University Medical Center</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Division of Neurology Duke University Medical Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Silver, D" sort="Silver, D" uniqKey="Silver D" first="D." last="Silver">D. Silver</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Coastal Neurological Medical Group, Inc</s1>
<s2>La Jolla, CA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>La Jolla, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mendis, T" sort="Mendis, T" uniqKey="Mendis T" first="T." last="Mendis">T. Mendis</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Parkinson's and Neurodegenerative Disorders Clinic</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Parkinson's and Neurodegenerative Disorders Clinic</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sutton, J" sort="Sutton, J" uniqKey="Sutton J" first="J." last="Sutton">J. Sutton</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Pacific Neuroscience Medical Group, Inc</s1>
<s2>Oxnard, CA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Oxnard, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mori, A" sort="Mori, A" uniqKey="Mori A" first="A." last="Mori">A. Mori</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Kyowa Pharmaceutical, Inc</s1>
<s2>Princeton, NJ</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Princeton, NJ</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chaikin, P" sort="Chaikin, P" uniqKey="Chaikin P" first="P." last="Chaikin">P. Chaikin</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Kyowa Pharmaceutical, Inc</s1>
<s2>Princeton, NJ</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Princeton, NJ</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sussman, N M" sort="Sussman, N M" uniqKey="Sussman N" first="N. M." last="Sussman">N. M. Sussman</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Kyowa Pharmaceutical, Inc</s1>
<s2>Princeton, NJ</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Princeton, NJ</wicri:noRegion>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">08-0298557</idno>
<date when="2008">2008</date>
<idno type="stanalyst">PASCAL 08-0298557 INIST</idno>
<idno type="RBID">Pascal:08-0298557</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000641</idno>
<idno type="wicri:Area/PascalFrancis/Curation">000669</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">000575</idno>
<idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000575</idno>
<idno type="wicri:doubleKey">0028-3878:2008:Stacy M:a:week:placebo</idno>
<idno type="wicri:Area/Main/Merge">002636</idno>
<idno type="wicri:Area/Main/Curation">002420</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease</title>
<author><name sortKey="Stacy, M" sort="Stacy, M" uniqKey="Stacy M" first="M." last="Stacy">M. Stacy</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Division of Neurology Duke University Medical Center</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Division of Neurology Duke University Medical Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Silver, D" sort="Silver, D" uniqKey="Silver D" first="D." last="Silver">D. Silver</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Coastal Neurological Medical Group, Inc</s1>
<s2>La Jolla, CA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>La Jolla, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mendis, T" sort="Mendis, T" uniqKey="Mendis T" first="T." last="Mendis">T. Mendis</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Parkinson's and Neurodegenerative Disorders Clinic</s1>
<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Parkinson's and Neurodegenerative Disorders Clinic</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sutton, J" sort="Sutton, J" uniqKey="Sutton J" first="J." last="Sutton">J. Sutton</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Pacific Neuroscience Medical Group, Inc</s1>
<s2>Oxnard, CA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Oxnard, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mori, A" sort="Mori, A" uniqKey="Mori A" first="A." last="Mori">A. Mori</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Kyowa Pharmaceutical, Inc</s1>
<s2>Princeton, NJ</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Princeton, NJ</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chaikin, P" sort="Chaikin, P" uniqKey="Chaikin P" first="P." last="Chaikin">P. Chaikin</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Kyowa Pharmaceutical, Inc</s1>
<s2>Princeton, NJ</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Princeton, NJ</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sussman, N M" sort="Sussman, N M" uniqKey="Sussman N" first="N. M." last="Sussman">N. M. Sussman</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Kyowa Pharmaceutical, Inc</s1>
<s2>Princeton, NJ</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Princeton, NJ</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Neurology</title>
<title level="j" type="abbreviated">Neurology</title>
<idno type="ISSN">0028-3878</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Neurology</title>
<title level="j" type="abbreviated">Neurology</title>
<idno type="ISSN">0028-3878</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Istradefylline</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Placebo</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term>
<term>Pathologie du système nerveux</term>
<term>Placebo</term>
<term>Istradéfylline</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: The safety and efficacy of istradefylline, a selective adenosine A<sub>2A</sub>
receptor antagonist, was evaluated in a 12-week, double-blind study in levodopa-treated Parkinson disease (PD) subjects with motor complications. Methods: Levodopa-treated PD subjects (n = 395) received istradefylline 20 mg/day (n = 163), istradefylline 60 mg/day (n = 155), or placebo (n = 77) at 40 sites. The primary efficacy variable was the change in the percentage of time per day spent in the OFF state. Secondary measurements assessed change in ON time, Unified Parkinson's Disease Rating Scale, and Clinical Global Impression. Safety monitoring included clinical laboratory, electrocardiograms, vital signs, physical/neurologic examinations, and adverse events (AEs). Results: Changes from baseline to endpoint in the percentage OFF time in the active groups compared with placebo were -4.35% (95% Cl -8.16 to -0.54; p = 0.026) for istradefylline 20 mg/day and -4.49% (95% Cl -8.35 to -0.62; p = 0.024) for 60 mg/day; these changes were significant (analysis of covariance). For total hours, istradefylline demonstrated mean differences from placebo of -0.64 hours (95% Cl -1.30 to 0.01) for 20 mg/day and -0.77 hours (95% Cl -1.44 to -0.11) for 60 mg/day (p = 0.065; overall treatment effect). Clinical response occurred by the second week and was maintained throughout the study. Istradefylline was well tolerated. The common AEs were dyskinesia, nausea, dizziness, and hallucinations. Conclusions: Istradefylline demonstrated a significant reduction in the percentage of awake time per day spent in the OFF state, which resulted in a clinically meaningful reduction in OFF time, without an increase in ON time with troublesome dyskinesia, and was well tolerated as adjunctive treatment to levodopa in Parkinson disease.</div>
</front>
</TEI>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Canada/explor/ParkinsonCanadaV1/Data/Main/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002420 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Curation/biblio.hfd -nk 002420 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Canada |area= ParkinsonCanadaV1 |flux= Main |étape= Curation |type= RBID |clé= Pascal:08-0298557 |texte= A 12-week, placebo-controlled study (6002-US-006) of istradefylline in Parkinson disease }}
This area was generated with Dilib version V0.6.29. |