MovDisordV3, PascalFrancis, Corpus, bibRecord, 000998

Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study

Identifieur interne : 000998 ( PascalFrancis/Corpus ); précédent : 000997; suivant : 000999

Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study

Auteurs : Yoshikuni Mizuno ; Kazuko Hasegawa ; Tomoyoshi Kondo ; Sadako Kuno ; Mitsutoshi Yamamoto

Source :

Movement disorders [ 0885-3185 ] ; 2010.

RBID : Pascal:10-0377340

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Istradéfylline, Adénosine, Lévodopa.

English descriptors

KwdEn :
- Adenosine, Istradefylline, Levodopa, Nervous system diseases, Parkinson disease.

Abstract

The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose or 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/ day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefy line at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefy line was well tolerated at both doses.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0885-3185`
A03		`1`		`@0 Mov. disord.`
A05				`@2 25`
A06				`@2 10`
A08	`01`	`1`	`ENG`	`@1 Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study`
A11	`01`	`1`		`@1 MIZUNO (Yoshikuni)`
A11	`02`	`1`		`@1 HASEGAWA (Kazuko)`
A11	`03`	`1`		`@1 KONDO (Tomoyoshi)`
A11	`04`	`1`		`@1 KUNO (Sadako)`
A11	`05`	`1`		`@1 YAMAMOTO (Mitsutoshi)`
A14	`01`			`@1 Department of Neurology, Research Institute for Diseases of Old Age, Juntendo University School of Medicine @2 Tokyo @3 JPN @Z 1 aut.`
A14	`02`			`@1 Department of Neurology, National Hospital Organization Sagamihara National Hospital @2 Kanagawa @3 JPN @Z 2 aut.`
A14	`03`			`@1 Department of Neurology, Wakayama Medical University Hospital @2 Wakayama @3 JPN @Z 3 aut.`
A14	`04`			`@1 Department of Neurology, National Center of Neurology and Psychiatry @2 Tokyo @3 JPN @Z 4 aut.`
A14	`05`			`@1 Department of Neurology, Kagawa Prefectural Central Hospital @2 Kagawa @3 JPN @Z 5 aut.`
A17	`01`	`1`		`@1 Japanese Istradefylline Study Group @3 JPN`
A20				`@1 1437-1443`
A21				`@1 2010`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 20953 @5 354000194762830150`
A44				`@0 0000 @1 © 2010 INIST-CNRS. All rights reserved.`
A45				`@0 27 ref.`
A47	`01`	`1`		`@0 10-0377340`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Movement disorders`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose or 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/ day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefy line at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefy line was well tolerated at both doses.
C02	`01`	`X`		`@0 002B17`
C02	`02`	`X`		`@0 002B17G`
C03	`01`	`X`	`FRE`	`@0 Maladie de Parkinson @2 NM @5 01`
C03	`01`	`X`	`ENG`	`@0 Parkinson disease @2 NM @5 01`
C03	`01`	`X`	`SPA`	`@0 Parkinson enfermedad @2 NM @5 01`
C03	`02`	`X`	`FRE`	`@0 Pathologie du système nerveux @5 02`
C03	`02`	`X`	`ENG`	`@0 Nervous system diseases @5 02`
C03	`02`	`X`	`SPA`	`@0 Sistema nervioso patología @5 02`
C03	`03`	`X`	`FRE`	`@0 Istradéfylline @2 FR @5 09`
C03	`03`	`X`	`ENG`	`@0 Istradefylline @2 FR @5 09`
C03	`03`	`X`	`SPA`	`@0 Istradefilina @2 FR @5 09`
C03	`04`	`X`	`FRE`	`@0 Adénosine @2 NK @2 FR @5 10`
C03	`04`	`X`	`ENG`	`@0 Adenosine @2 NK @2 FR @5 10`
C03	`04`	`X`	`SPA`	`@0 Adenosina @2 NK @2 FR @5 10`
C03	`05`	`X`	`FRE`	`@0 Lévodopa @2 NK @2 FR @5 11`
C03	`05`	`X`	`ENG`	`@0 Levodopa @2 NK @2 FR @5 11`
C03	`05`	`X`	`SPA`	`@0 Levodopa @2 NK @2 FR @5 11`
C07	`01`	`X`	`FRE`	`@0 Pathologie de l'encéphale @5 37`
C07	`01`	`X`	`ENG`	`@0 Cerebral disorder @5 37`
C07	`01`	`X`	`SPA`	`@0 Encéfalo patología @5 37`
C07	`02`	`X`	`FRE`	`@0 Syndrome extrapyramidal @5 38`
C07	`02`	`X`	`ENG`	`@0 Extrapyramidal syndrome @5 38`
C07	`02`	`X`	`SPA`	`@0 Extrapiramidal síndrome @5 38`
C07	`03`	`X`	`FRE`	`@0 Maladie dégénérative @5 39`
C07	`03`	`X`	`ENG`	`@0 Degenerative disease @5 39`
C07	`03`	`X`	`SPA`	`@0 Enfermedad degenerativa @5 39`
C07	`04`	`X`	`FRE`	`@0 Pathologie du système nerveux central @5 40`
C07	`04`	`X`	`ENG`	`@0 Central nervous system disease @5 40`
C07	`04`	`X`	`SPA`	`@0 Sistema nervosio central patología @5 40`
N21				`@1 242`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 10-0377340 INIST
ET :	Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study
AU :	MIZUNO (Yoshikuni); HASEGAWA (Kazuko); KONDO (Tomoyoshi); KUNO (Sadako); YAMAMOTO (Mitsutoshi)
AF :	Department of Neurology, Research Institute for Diseases of Old Age, Juntendo University School of Medicine/Tokyo/Japon (1 aut.); Department of Neurology, National Hospital Organization Sagamihara National Hospital/Kanagawa/Japon (2 aut.); Department of Neurology, Wakayama Medical University Hospital/Wakayama/Japon (3 aut.); Department of Neurology, National Center of Neurology and Psychiatry/Tokyo/Japon (4 aut.); Department of Neurology, Kagawa Prefectural Central Hospital/Kagawa/Japon (5 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2010; Vol. 25; No. 10; Pp. 1437-1443; Bibl. 27 ref.
LA :	Anglais
EA :	The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose or 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/ day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefy line at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefy line was well tolerated at both doses.
CC :	002B17; 002B17G
FD :	Maladie de Parkinson; Pathologie du système nerveux; Istradéfylline; Adénosine; Lévodopa
FG :	Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central
ED :	Parkinson disease; Nervous system diseases; Istradefylline; Adenosine; Levodopa
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Parkinson enfermedad; Sistema nervioso patología; Istradefilina; Adenosina; Levodopa
LO :	INIST-20953.354000194762830150
ID :	10-0377340

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Pascal:10-0377340

Le document en format XML

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<front><div type="abstract" xml:lang="en">The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose or 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/ day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefy line at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefy line was well tolerated at both doses.</div>
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<fC01 i1="01" l="ENG"><s0>The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose or 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/ day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefy line at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefy line was well tolerated at both doses.</s0>
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<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Istradéfylline</s0>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Istradefylline</s0>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Istradefilina</s0>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Adénosine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Adenosine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Adenosina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>37</s5>
</fC07>
<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>242</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 10-0377340 INIST</NO>
<ET>Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study</ET>
<AU>MIZUNO (Yoshikuni); HASEGAWA (Kazuko); KONDO (Tomoyoshi); KUNO (Sadako); YAMAMOTO (Mitsutoshi)</AU>
<AF>Department of Neurology, Research Institute for Diseases of Old Age, Juntendo University School of Medicine/Tokyo/Japon (1 aut.); Department of Neurology, National Hospital Organization Sagamihara National Hospital/Kanagawa/Japon (2 aut.); Department of Neurology, Wakayama Medical University Hospital/Wakayama/Japon (3 aut.); Department of Neurology, National Center of Neurology and Psychiatry/Tokyo/Japon (4 aut.); Department of Neurology, Kagawa Prefectural Central Hospital/Kagawa/Japon (5 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2010; Vol. 25; No. 10; Pp. 1437-1443; Bibl. 27 ref.</SO>
<LA>Anglais</LA>
<EA>The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose or 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/ day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefy line at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefy line was well tolerated at both doses.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du   système nerveux; Istradéfylline; Adénosine; Lévodopa</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du   système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; Istradefylline; Adenosine; Levodopa</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Istradefilina; Adenosina; Levodopa</SD>
<LO>INIST-20953.354000194762830150</LO>
<ID>10-0377340</ID>
</server>
</inist>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study

Clinical Efficacy of Istradefylline (KW-6002) in Parkinson's Disease: A Randomized, Controlled Study

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