Movement Disorders (revue)

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Rationale for Delayed-Start Study of Pramipexole in Parkinson's Disease: The PROUD Study

Identifieur interne : 000956 ( PascalFrancis/Corpus ); précédent : 000955; suivant : 000957

Rationale for Delayed-Start Study of Pramipexole in Parkinson's Disease: The PROUD Study

Auteurs : Anthony H. V. Schapira ; Stefan Albrecht ; Paolo Barone ; Cynthia L. Comella ; Michael P. Mcdermott ; Yoshikuni Mizuno ; Werner Poewe ; Olivier Rascol ; Kenneth Marek

Source :

RBID : Pascal:10-0413282

Descripteurs français

English descriptors

Abstract

Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
A01 01  1    @0 0885-3185
A03   1    @0 Mov. disord.
A05       @2 25
A06       @2 11
A08 01  1  ENG  @1 Rationale for Delayed-Start Study of Pramipexole in Parkinson's Disease: The PROUD Study
A11 01  1    @1 SCHAPIRA (Anthony H. V.)
A11 02  1    @1 ALBRECHT (Stefan)
A11 03  1    @1 BARONE (Paolo)
A11 04  1    @1 COMELLA (Cynthia L.)
A11 05  1    @1 MCDERMOTT (Michael P.)
A11 06  1    @1 MIZUNO (Yoshikuni)
A11 07  1    @1 POEWE (Werner)
A11 08  1    @1 RASCOL (Olivier)
A11 09  1    @1 MAREK (Kenneth)
A14 01      @1 Department of Clinical Neurosciences, Institute of Neurology, University College London @2 London @3 GBR @Z 1 aut.
A14 02      @1 Boehringer Ingelheim GmbH, CD Medical Affairs CNS @2 Ingelheim @3 DEU @Z 2 aut.
A14 03      @1 Department of Neurological Sciences, University of Naples, Federico II and IDC-Hermitage-Capodimonte @2 Naples @3 ITA @Z 3 aut.
A14 04      @1 Department of Neurological Sciences, Rush University Medical Center @2 Chicago, Illinois @3 USA @Z 4 aut.
A14 05      @1 Department of Biostatistics and Computational Biology, University of Rochester Medical Center @2 Rochester, New York @3 USA @Z 5 aut.
A14 06      @1 Department of Neurology, Juntendo University School of Medicine @2 Bunkyo-ku, Tokyo @3 JPN @Z 6 aut.
A14 07      @1 Department of Neurology, Innsbruck Medical University @2 Innsbruck @3 AUT @Z 7 aut.
A14 08      @1 Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital @2 Toulouse @3 FRA @Z 8 aut.
A14 09      @1 Institute for Neurodegenerative Disorders @2 New Haven, Connecticut @3 USA @Z 9 aut.
A20       @1 1627-1632
A21       @1 2010
A23 01      @0 ENG
A43 01      @1 INIST @2 20953 @5 354000192608100140
A44       @0 0000 @1 © 2010 INIST-CNRS. All rights reserved.
A45       @0 33 ref.
A47 01  1    @0 10-0413282
A60       @1 P
A61       @0 A
A64 01  1    @0 Movement disorders
A66 01      @0 USA
C01 01    ENG  @0 Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.
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 Pramipexole @2 NK @2 FR @5 09
C03 03  X  ENG  @0 Pramipexole @2 NK @2 FR @5 09
C03 03  X  SPA  @0 Pramipexol @2 NK @2 FR @5 09
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       @1 270
N44 01      @1 OTO
N82       @1 OTO

Format Inist (serveur)

NO : PASCAL 10-0413282 INIST
ET : Rationale for Delayed-Start Study of Pramipexole in Parkinson's Disease: The PROUD Study
AU : SCHAPIRA (Anthony H. V.); ALBRECHT (Stefan); BARONE (Paolo); COMELLA (Cynthia L.); MCDERMOTT (Michael P.); MIZUNO (Yoshikuni); POEWE (Werner); RASCOL (Olivier); MAREK (Kenneth)
AF : Department of Clinical Neurosciences, Institute of Neurology, University College London/London/Royaume-Uni (1 aut.); Boehringer Ingelheim GmbH, CD Medical Affairs CNS/Ingelheim/Allemagne (2 aut.); Department of Neurological Sciences, University of Naples, Federico II and IDC-Hermitage-Capodimonte/Naples/Italie (3 aut.); Department of Neurological Sciences, Rush University Medical Center/Chicago, Illinois/Etats-Unis (4 aut.); Department of Biostatistics and Computational Biology, University of Rochester Medical Center/Rochester, New York/Etats-Unis (5 aut.); Department of Neurology, Juntendo University School of Medicine/Bunkyo-ku, Tokyo/Japon (6 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (7 aut.); Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital/Toulouse/France (8 aut.); Institute for Neurodegenerative Disorders/New Haven, Connecticut/Etats-Unis (9 aut.)
DT : Publication en série; Niveau analytique
SO : Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2010; Vol. 25; No. 11; Pp. 1627-1632; Bibl. 33 ref.
LA : Anglais
EA : Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.
CC : 002B17; 002B17G
FD : Maladie de Parkinson; Pathologie du système nerveux; Pramipexole
FG : Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central
ED : Parkinson disease; Nervous system diseases; Pramipexole
EG : Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD : Parkinson enfermedad; Sistema nervioso patología; Pramipexol
LO : INIST-20953.354000192608100140
ID : 10-0413282

Links to Exploration step

Pascal:10-0413282

Le document en format XML

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<div type="abstract" xml:lang="en">Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.</div>
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<s5>40</s5>
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<ET>Rationale for Delayed-Start Study of Pramipexole in Parkinson's Disease: The PROUD Study</ET>
<AU>SCHAPIRA (Anthony H. V.); ALBRECHT (Stefan); BARONE (Paolo); COMELLA (Cynthia L.); MCDERMOTT (Michael P.); MIZUNO (Yoshikuni); POEWE (Werner); RASCOL (Olivier); MAREK (Kenneth)</AU>
<AF>Department of Clinical Neurosciences, Institute of Neurology, University College London/London/Royaume-Uni (1 aut.); Boehringer Ingelheim GmbH, CD Medical Affairs CNS/Ingelheim/Allemagne (2 aut.); Department of Neurological Sciences, University of Naples, Federico II and IDC-Hermitage-Capodimonte/Naples/Italie (3 aut.); Department of Neurological Sciences, Rush University Medical Center/Chicago, Illinois/Etats-Unis (4 aut.); Department of Biostatistics and Computational Biology, University of Rochester Medical Center/Rochester, New York/Etats-Unis (5 aut.); Department of Neurology, Juntendo University School of Medicine/Bunkyo-ku, Tokyo/Japon (6 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (7 aut.); Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital/Toulouse/France (8 aut.); Institute for Neurodegenerative Disorders/New Haven, Connecticut/Etats-Unis (9 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2010; Vol. 25; No. 11; Pp. 1627-1632; Bibl. 33 ref.</SO>
<LA>Anglais</LA>
<EA>Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.</EA>
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<SD>Parkinson enfermedad; Sistema nervioso patología; Pramipexol</SD>
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