MovDisordV3, Main, Curation, bibRecord, 002621

Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations

Identifieur interne : 002621 ( Main/Curation ); précédent : 002620; suivant : 002622

Study 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.

RBID : ISTEX:D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4

Descripteurs français

Pascal (Inist)
- Fluctuation, Homme, Istradéfylline, Lévodopa, Maladie de Parkinson, Pathologie du système nerveux, Traitement.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Aged, Analysis of Variance, Antiparkinson Agents (therapeutic use), Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Dyskinesia, Drug-Induced (drug therapy), Dyskinesia, Drug-Induced (etiology), Female, Fluctuations, Human, Humans, Istradefylline, KW‐6002, Levodopa, Levodopa (adverse effects), Male, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson Disease (physiopathology), Parkinson disease, Parkinson's disease, Purines (therapeutic use), Questionnaires, Severity of Illness Index, Time Factors, Treatment, istradefylline, motor fluctuations, off time, treatment.
MESH :
- chemical , adverse effects : Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Purines.
- drug therapy : Dyskinesia, Drug-Induced, Parkinson Disease.
- etiology : Dyskinesia, Drug-Induced.
- physiopathology : Parkinson Disease.
- Aged, Analysis of Variance, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Male, Middle Aged, Questionnaires, Severity of Illness Index, Time Factors.

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:

https://api.istex.fr/document/D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4/fulltext/pdf

DOI: 10.1002/mds.22095

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ISTEX:D16EBA1B882CDB4F40CD3FAF655B95EF7EB56DD4

Le document en format XML

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<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>
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<author><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name>
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<s2>Princeton, New Jersey</s2>
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</author>
<author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M." last="Sussman">Neil M. Sussman</name>
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<series><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Fluctuations</term>
<term>Human</term>
<term>Istradefylline</term>
<term>Levodopa</term>
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<term>Parkinson disease</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term>
<term>Pathologie du   système nerveux</term>
<term>Istradéfylline</term>
<term>Homme</term>
<term>Lévodopa</term>
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<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 A<sub>2A</sub>
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.</div>
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<author><name sortKey="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M." last="Shulman">Lisa M. Shulman</name>
</author>
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<author><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W." last="Roberts">John W. Roberts</name>
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<author><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name>
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<author><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name>
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<author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M." last="Sussman">Neil M. Sussman</name>
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<wicri:regionArea>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida</wicri:regionArea>
<placeName><region type="state">Floride</region>
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</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
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<author><name sortKey="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M." last="Shulman">Lisa M. Shulman</name>
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</affiliation>
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<author><name sortKey="Trugman, Joel M" sort="Trugman, Joel M" uniqKey="Trugman J" first="Joel M." last="Trugman">Joel M. Trugman</name>
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<author><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W." last="Roberts">John W. Roberts</name>
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<author><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name>
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<author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M." last="Sussman">Neil M. Sussman</name>
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<series><title level="j">Movement Disorders</title>
<title level="j" type="sub">Official Journal of the Movement Disorder Society</title>
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<term>Analysis of Variance</term>
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<term>Double-Blind Method</term>
<term>Drug-Related Side Effects and Adverse Reactions</term>
<term>Dyskinesia, Drug-Induced (drug therapy)</term>
<term>Dyskinesia, Drug-Induced (etiology)</term>
<term>Female</term>
<term>Humans</term>
<term>KW‐6002</term>
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<term>Questionnaires</term>
<term>Severity of Illness Index</term>
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<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>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations

Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations

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