Rationale for Delayed-Start Study of Pramipexole in Parkinson's Disease: The PROUD Study
Identifieur interne : 000526 ( PascalFrancis/Corpus ); précédent : 000525; suivant : 000527Rationale 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 MarekSource :
- Movement disorders [ 0885-3185 ] ; 2010.
Descripteurs français
- Pascal (Inist)
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.
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Format Inist (serveur)
NO : | PASCAL 10-0413282 INIST |
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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 |
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Pascal:10-0413282Le document en format XML
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<front><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>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>270</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
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<server><NO>PASCAL 10-0413282 INIST</NO>
<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>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du système nerveux; Pramipexole</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; Pramipexole</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Pramipexol</SD>
<LO>INIST-20953.354000192608100140</LO>
<ID>10-0413282</ID>
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