MovDisordV3, PascalFrancis, Corpus, bibRecord, 002099

Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients

Identifieur interne : 002099 ( PascalFrancis/Corpus ); précédent : 002098; suivant : 002100

Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients

Auteurs : Matthew B. Stern ; Kenneth L. Marek ; Joseph Friedman ; Robert A. Hauser ; Peter A. Lewitt ; Daniel Tarsy ; C. Warren Olanow

Source :

Movement disorders [ 0885-3185 ] ; 2004.

RBID : Pascal:04-0494461

Descripteurs français

Pascal (Inist)
- Parkinson maladie, Rasagiline, Homme, Système nerveux pathologie.

English descriptors

KwdEn :
- Human, Nervous system diseases, Parkinson disease, Rasagiline.

Abstract

Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A03		`1`		`@0 Mov. disord.`
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A08	`01`	`1`	`ENG`	`@1 Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients`
A11	`01`	`1`		`@1 STERN (Matthew B.)`
A11	`02`	`1`		`@1 MAREK (Kenneth L.)`
A11	`03`	`1`		`@1 FRIEDMAN (Joseph)`
A11	`04`	`1`		`@1 HAUSER (Robert A.)`
A11	`05`	`1`		`@1 LEWITT (Peter A.)`
A11	`06`	`1`		`@1 TARSY (Daniel)`
A11	`07`	`1`		`@1 OLANOW (C. Warren)`
A14	`01`			`@1 University of Pennsylvania @2 Philadelphia, Pennsylvania @3 USA @Z 1 aut.`
A14	`02`			`@1 Yale University School of Medicine @2 New Haven, Connecticut @3 USA @Z 2 aut.`
A14	`03`			`@1 Brown University School of Medicine @2 Providence, Rhode Island @3 USA @Z 3 aut.`
A14	`04`			`@1 University of South Florida @2 Tampa, Florida @3 USA @Z 4 aut.`
A14	`05`			`@1 Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine @2 Detroit @3 USA @Z 5 aut.`
A14	`06`			`@1 Clinical Neuroscience Center @2 Southfield, Michigan @3 USA @Z 5 aut.`
A14	`07`			`@1 Beth Israel Deaconess Medical Center @2 Boston, Massachusetts @3 USA @Z 6 aut.`
A14	`08`			`@1 Mount Sinai School of Medicine @2 New York, New York @3 USA @Z 7 aut.`
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A21				`@1 2004`
A23	`01`			`@0 ENG`
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A44				`@0 0000 @1 © 2004 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.
C02	`01`	`X`		`@0 002B17`
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C03	`02`	`X`	`FRE`	`@0 Rasagiline @2 NK @2 FR @5 02`
C03	`02`	`X`	`ENG`	`@0 Rasagiline @2 NK @2 FR @5 02`
C03	`02`	`X`	`SPA`	`@0 Rasagilina @2 NK @2 FR @5 02`
C03	`03`	`X`	`FRE`	`@0 Homme @5 03`
C03	`03`	`X`	`ENG`	`@0 Human @5 03`
C03	`03`	`X`	`SPA`	`@0 Hombre @5 03`
C03	`04`	`X`	`FRE`	`@0 Système nerveux pathologie @5 04`
C03	`04`	`X`	`ENG`	`@0 Nervous system diseases @5 04`
C03	`04`	`X`	`SPA`	`@0 Sistema nervioso patología @5 04`
C07	`01`	`X`	`FRE`	`@0 Encéphale pathologie @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 Extrapyramidal syndrome @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 Système nerveux central pathologie @5 40`
C07	`04`	`X`	`ENG`	`@0 Central nervous system disease @5 40`
C07	`04`	`X`	`SPA`	`@0 Sistema nervosio central patología @5 40`
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N44	`01`			`@1 OTO`
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Format Inist (serveur)

NO :	PASCAL 04-0494461 INIST
ET :	Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients
AU :	STERN (Matthew B.); MAREK (Kenneth L.); FRIEDMAN (Joseph); HAUSER (Robert A.); LEWITT (Peter A.); TARSY (Daniel); OLANOW (C. Warren)
AF :	University of Pennsylvania/Philadelphia, Pennsylvania/Etats-Unis (1 aut.); Yale University School of Medicine/New Haven, Connecticut/Etats-Unis (2 aut.); Brown University School of Medicine/Providence, Rhode Island/Etats-Unis (3 aut.); University of South Florida/Tampa, Florida/Etats-Unis (4 aut.); Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine/Detroit/Etats-Unis (5 aut.); Clinical Neuroscience Center/Southfield, Michigan/Etats-Unis (5 aut.); Beth Israel Deaconess Medical Center/Boston, Massachusetts/Etats-Unis (6 aut.); Mount Sinai School of Medicine/New York, New York/Etats-Unis (7 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2004; Vol. 19; No. 8; Pp. 916-923; Bibl. 32 ref.
LA :	Anglais
EA :	Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.
CC :	002B17
FD :	Parkinson maladie; Rasagiline; Homme; Système nerveux pathologie
FG :	Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie
ED :	Parkinson disease; Rasagiline; Human; Nervous system diseases
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Parkinson enfermedad; Rasagilina; Hombre; Sistema nervioso patología
LO :	INIST-20953.354000122179160060
ID :	04-0494461

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Pascal:04-0494461

Le document en format XML

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<front><div type="abstract" xml:lang="en">Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.</div>
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<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Rasagiline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Rasagiline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Rasagilina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Homme</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Human</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Hombre</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>04</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Encéphale pathologie</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>Extrapyramidal syndrome</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>Système nerveux central pathologie</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>278</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 04-0494461 INIST</NO>
<ET>Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients</ET>
<AU>STERN (Matthew B.); MAREK (Kenneth L.); FRIEDMAN (Joseph); HAUSER (Robert A.); LEWITT (Peter A.); TARSY (Daniel); OLANOW (C. Warren)</AU>
<AF>University of Pennsylvania/Philadelphia, Pennsylvania/Etats-Unis (1 aut.); Yale University School of Medicine/New Haven, Connecticut/Etats-Unis (2 aut.); Brown University School of Medicine/Providence, Rhode Island/Etats-Unis (3 aut.); University of South Florida/Tampa, Florida/Etats-Unis (4 aut.); Departments of Neurology, Psychiatry and Behavioral Neuroscience, Wayne State University School of Medicine/Detroit/Etats-Unis (5 aut.); Clinical Neuroscience Center/Southfield, Michigan/Etats-Unis (5 aut.); Beth Israel Deaconess Medical Center/Boston, Massachusetts/Etats-Unis (6 aut.); Mount Sinai School of Medicine/New York, New York/Etats-Unis (7 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2004; Vol. 19; No. 8; Pp. 916-923; Bibl. 32 ref.</SO>
<LA>Anglais</LA>
<EA>Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.</EA>
<CC>002B17</CC>
<FD>Parkinson maladie; Rasagiline; Homme; Système nerveux pathologie</FD>
<FG>Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie</FG>
<ED>Parkinson disease; Rasagiline; Human; Nervous system diseases</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Rasagilina; Hombre; Sistema nervioso patología</SD>
<LO>INIST-20953.354000122179160060</LO>
<ID>04-0494461</ID>
</server>
</inist>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients

Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients

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