Adenosine A2A Receptor Antagonist Istradefylline (KW-6002) Reduces "Off' Time in Parkinson's Disease : A Double-Blind, Randomized, Multicenter Clinical Trial (6002-US-005)
Identifieur interne : 000661 ( PascalFrancis/Corpus ); précédent : 000660; suivant : 000662Adenosine A2A Receptor Antagonist Istradefylline (KW-6002) Reduces "Off' Time in Parkinson's Disease : A Double-Blind, Randomized, Multicenter Clinical Trial (6002-US-005)
Auteurs : Peter A. Lewitt ; M. Guttman ; James W. Tetrud ; Paul J. Tuite ; Akihisa Mori ; Philip Chaikin ; Neil M. SussmanSource :
- Annals of neurology [ 0364-5134 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Objective: Based on new understanding of nondopaminergic pathways involved in Parkinson's disease (PD) pathophysiology, a selective adenosine A2A receptor antagonist, istradefylline, shows promise for the treatment of PD. Methods: Istradefylline (40mg/day) was studied in levodopa-treated PD subjects experiencing prominent wearing-off motor fluctuations. At 23 North American sites, 196 subjects were randomized in a double-blind, 12-week outpatient clinical trial of istradefylline (114 completing the trial) or placebo (58 completing the trial). The primary efficacy measure was change from baseline to end point in the percentage of daily awake "off" time, recorded by subjects using a patient PD diary. Secondary end points evaluated "on" time (including "on time with dyskinesia"), the Unified Parkinson's Disease Rating Scale, and a Clinical Global Impression-Improvement of Illness score. Clinical laboratory, electrocardiograms, vital signs, and adverse event monitoring comprised the safety monitoring. Results: After randomization, approximately 88% of subjects completed the double-blind period. Compared with baseline, the decrease of daily awake "off' time for istradefylline was a mean (± standard deviation) of -10.8 ± 16.6% (95% confidence interval, -13.46 to -7.52) and for placebo, -4.0 ± 15.7% (95% confidence interval, -7.73-0.31; p = 0.007 using two-way analysis of variance). This effect corresponded to changes from baseline in total daily awake "off' time of -1.8 ± 2.8 hours for istradefylline and -0.6 ± 2.7 hours for placebo (p = 0.005). Treatment-emergent adverse effects with istradefylline were generally mild. Interpretation: Istradefylline was safe, well tolerated, and offered a clinically meaningful reduction in "off' time without increased troublesome dyskinesia.
Notice en format standard (ISO 2709)
Pour connaître la documentation sur le format Inist Standard.
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Format Inist (serveur)
NO : | PASCAL 08-0192208 INIST |
---|---|
ET : | Adenosine A2A Receptor Antagonist Istradefylline (KW-6002) Reduces "Off' Time in Parkinson's Disease : A Double-Blind, Randomized, Multicenter Clinical Trial (6002-US-005) |
AU : | LEWITT (Peter A.); GUTTMAN (M.); TETRUD (James W.); TUITE (Paul J.); MORI (Akihisa); CHAIKIN (Philip); SUSSMAN (Neil M.) |
AF : | Department of Neurology, Henry Ford Hospital/Etats-Unis (1 aut.); Department of Neurology, Wayne State University School of Medicine/Detroit, MI/Etats-Unis (1 aut.); Division of Neurology, Department of Medicine, University of Toronto/Toronto, Ontario/Canada (2 aut.); The Parkinson Institute/Sunnyvale, CA/Etats-Unis (3 aut.); Department of Neurology, University of Minnesota/Minneapolis, MN/Etats-Unis (4 aut.); Kyowa Hakko Kogyo Co., Ltd/Tokyo/Japon (5 aut.); Kyowa Pharmaceutical, Inc/Princeton, NJ/Etats-Unis (6 aut., 7 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | Annals of neurology; ISSN 0364-5134; Coden ANNED3; Royaume-Uni; Da. 2008; Vol. 63; No. 3; Pp. 295-302; Bibl. 24 ref. |
LA : | Anglais |
EA : | Objective: Based on new understanding of nondopaminergic pathways involved in Parkinson's disease (PD) pathophysiology, a selective adenosine A2A receptor antagonist, istradefylline, shows promise for the treatment of PD. Methods: Istradefylline (40mg/day) was studied in levodopa-treated PD subjects experiencing prominent wearing-off motor fluctuations. At 23 North American sites, 196 subjects were randomized in a double-blind, 12-week outpatient clinical trial of istradefylline (114 completing the trial) or placebo (58 completing the trial). The primary efficacy measure was change from baseline to end point in the percentage of daily awake "off" time, recorded by subjects using a patient PD diary. Secondary end points evaluated "on" time (including "on time with dyskinesia"), the Unified Parkinson's Disease Rating Scale, and a Clinical Global Impression-Improvement of Illness score. Clinical laboratory, electrocardiograms, vital signs, and adverse event monitoring comprised the safety monitoring. Results: After randomization, approximately 88% of subjects completed the double-blind period. Compared with baseline, the decrease of daily awake "off' time for istradefylline was a mean (± standard deviation) of -10.8 ± 16.6% (95% confidence interval, -13.46 to -7.52) and for placebo, -4.0 ± 15.7% (95% confidence interval, -7.73-0.31; p = 0.007 using two-way analysis of variance). This effect corresponded to changes from baseline in total daily awake "off' time of -1.8 ± 2.8 hours for istradefylline and -0.6 ± 2.7 hours for placebo (p = 0.005). Treatment-emergent adverse effects with istradefylline were generally mild. Interpretation: Istradefylline was safe, well tolerated, and offered a clinically meaningful reduction in "off' time without increased troublesome dyskinesia. |
CC : | 002B17; 002B17G |
FD : | Maladie de Parkinson; Pathologie du système nerveux; Récepteur adénosinique A2A; Istradéfylline; Etude multicentrique; Essai clinique |
FG : | Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central |
ED : | Parkinson disease; Nervous system diseases; A2A adenosine receptor; Istradefylline; Multicenter study; Clinical trial |
EG : | Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease |
SD : | Parkinson enfermedad; Sistema nervioso patología; Receptor adenosínico A2A; Istradefilina; Estudio multicéntrico; Ensayo clínico |
LO : | INIST-16555.354000183339310060 |
ID : | 08-0192208 |
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Pascal:08-0192208Le document en format XML
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<fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Syndrome extrapyramidal</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du système nerveux central</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>40</s5>
</fC07>
<fN21><s1>119</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 08-0192208 INIST</NO>
<ET>Adenosine A<sub>2A</sub>
Receptor Antagonist Istradefylline (KW-6002) Reduces "Off' Time in Parkinson's Disease : A Double-Blind, Randomized, Multicenter Clinical Trial (6002-US-005)</ET>
<AU>LEWITT (Peter A.); GUTTMAN (M.); TETRUD (James W.); TUITE (Paul J.); MORI (Akihisa); CHAIKIN (Philip); SUSSMAN (Neil M.)</AU>
<AF>Department of Neurology, Henry Ford Hospital/Etats-Unis (1 aut.); Department of Neurology, Wayne State University School of Medicine/Detroit, MI/Etats-Unis (1 aut.); Division of Neurology, Department of Medicine, University of Toronto/Toronto, Ontario/Canada (2 aut.); The Parkinson Institute/Sunnyvale, CA/Etats-Unis (3 aut.); Department of Neurology, University of Minnesota/Minneapolis, MN/Etats-Unis (4 aut.); Kyowa Hakko Kogyo Co., Ltd/Tokyo/Japon (5 aut.); Kyowa Pharmaceutical, Inc/Princeton, NJ/Etats-Unis (6 aut., 7 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Annals of neurology; ISSN 0364-5134; Coden ANNED3; Royaume-Uni; Da. 2008; Vol. 63; No. 3; Pp. 295-302; Bibl. 24 ref.</SO>
<LA>Anglais</LA>
<EA>Objective: Based on new understanding of nondopaminergic pathways involved in Parkinson's disease (PD) pathophysiology, a selective adenosine A<sub>2A</sub>
receptor antagonist, istradefylline, shows promise for the treatment of PD. Methods: Istradefylline (40mg/day) was studied in levodopa-treated PD subjects experiencing prominent wearing-off motor fluctuations. At 23 North American sites, 196 subjects were randomized in a double-blind, 12-week outpatient clinical trial of istradefylline (114 completing the trial) or placebo (58 completing the trial). The primary efficacy measure was change from baseline to end point in the percentage of daily awake "off" time, recorded by subjects using a patient PD diary. Secondary end points evaluated "on" time (including "on time with dyskinesia"), the Unified Parkinson's Disease Rating Scale, and a Clinical Global Impression-Improvement of Illness score. Clinical laboratory, electrocardiograms, vital signs, and adverse event monitoring comprised the safety monitoring. Results: After randomization, approximately 88% of subjects completed the double-blind period. Compared with baseline, the decrease of daily awake "off' time for istradefylline was a mean (± standard deviation) of -10.8 ± 16.6% (95% confidence interval, -13.46 to -7.52) and for placebo, -4.0 ± 15.7% (95% confidence interval, -7.73-0.31; p = 0.007 using two-way analysis of variance). This effect corresponded to changes from baseline in total daily awake "off' time of -1.8 ± 2.8 hours for istradefylline and -0.6 ± 2.7 hours for placebo (p = 0.005). Treatment-emergent adverse effects with istradefylline were generally mild. Interpretation: Istradefylline was safe, well tolerated, and offered a clinically meaningful reduction in "off' time without increased troublesome dyskinesia.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du système nerveux; Récepteur adénosinique A2A; Istradéfylline; Etude multicentrique; Essai clinique</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; A2A adenosine receptor; Istradefylline; Multicenter study; Clinical trial</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Receptor adenosínico A2A; Istradefilina; Estudio multicéntrico; Ensayo clínico</SD>
<LO>INIST-16555.354000183339310060</LO>
<ID>08-0192208</ID>
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