Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study
Identifieur interne : 000199 ( France/Analysis ); précédent : 000198; suivant : 000200Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study
Auteurs : Anthony H. V. Schapira [Royaume-Uni] ; Stefan Albrecht [Allemagne] ; Paolo Barone [Italie] ; Cynthia L. Comella [États-Unis] ; Michael P. Mcdermott [États-Unis] ; Yoshikuni Mizuno [Japon] ; Werner Poewe [Autriche] ; Olivier Rascol [France] ; Kenneth Marek [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-08-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adult, Aged, Antiparkinson Agents (administration & dosage), Benzothiazoles (administration & dosage), Double-Blind Method, Drug Delivery Systems (methods), Female, Humans, Male, Middle Aged, Nervous system diseases, Pain Measurement, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Pramipexole, Quality of Life, Severity of Illness Index, clinical trial, delayed‐start, neuroprotection, pramipexole.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Benzothiazoles.
- drug therapy : Parkinson Disease.
- methods : Drug Delivery Systems.
- Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Pain Measurement, Quality of Life, Severity of Illness Index.
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. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.23143
Affiliations:
- Allemagne, Autriche, France, Italie, Japon, Royaume-Uni, États-Unis
- Angleterre, Connecticut, Grand Londres, Illinois, Midi-Pyrénées, Tyrol (Land), État de New York
- Innsbruck, Londres, Tokyo, Toulouse
- Université Toulouse III - Paul Sabatier, Université de Toulouse, Université de médecine d'Innsbruck
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 000E02
- to stream Istex, to step Curation: 000E02
- to stream Istex, to step Checkpoint: 000742
- to stream PubMed, to step Corpus: 001807
- to stream PubMed, to step Curation: 001807
- to stream PubMed, to step Checkpoint: 001662
- to stream Ncbi, to step Merge: 002B95
- to stream Ncbi, to step Curation: 002B95
- to stream Ncbi, to step Checkpoint: 002B95
- to stream Main, to step Merge: 001E99
- to stream PascalFrancis, to step Corpus: 000956
- to stream PascalFrancis, to step Curation: 002363
- to stream PascalFrancis, to step Checkpoint: 000869
- to stream Main, to step Merge: 002456
- to stream Main, to step Curation: 001A63
- to stream Main, to step Exploration: 001A63
- to stream France, to step Extraction: 000199
Links to Exploration step
ISTEX:7B5F1EFF37468DE770370D07C19C11E1F8E02073Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study</title><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name></author><author><name sortKey="Albrecht, Stefan" sort="Albrecht, Stefan" uniqKey="Albrecht S" first="Stefan" last="Albrecht">Stefan Albrecht</name></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name></author><author><name sortKey="Mcdermott, Michael P" sort="Mcdermott, Michael P" uniqKey="Mcdermott M" first="Michael P." last="Mcdermott">Michael P. Mcdermott</name></author><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><country>Autriche</country><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><country>France</country><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Marek, Kenneth" sort="Marek, Kenneth" uniqKey="Marek K" first="Kenneth" last="Marek">Kenneth Marek</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:7B5F1EFF37468DE770370D07C19C11E1F8E02073</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1002/mds.23143</idno><idno type="url">https://api.istex.fr/document/7B5F1EFF37468DE770370D07C19C11E1F8E02073/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000E02</idno><idno type="wicri:Area/Istex/Curation">000E02</idno><idno type="wicri:Area/Istex/Checkpoint">000742</idno><idno type="wicri:doubleKey">0885-3185:2010:Schapira A:rationale:for:delayed</idno><idno type="wicri:source">PubMed</idno><idno type="RBID">pubmed:20544810</idno><idno type="wicri:Area/PubMed/Corpus">001807</idno><idno type="wicri:Area/PubMed/Curation">001807</idno><idno type="wicri:Area/PubMed/Checkpoint">001662</idno><idno type="wicri:Area/Ncbi/Merge">002B95</idno><idno type="wicri:Area/Ncbi/Curation">002B95</idno><idno type="wicri:Area/Ncbi/Checkpoint">002B95</idno><idno type="wicri:Area/Main/Merge">001E99</idno><idno type="wicri:source">INIST</idno><idno type="RBID">Pascal:10-0413282</idno><idno type="wicri:Area/PascalFrancis/Corpus">000956</idno><idno type="wicri:Area/PascalFrancis/Curation">002363</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000869</idno><idno type="wicri:doubleKey">0885-3185:2010:Schapira A:rationale:for:delayed</idno><idno type="wicri:Area/Main/Merge">002456</idno><idno type="wicri:Area/Main/Curation">001A63</idno><idno type="wicri:Area/Main/Exploration">001A63</idno><idno type="wicri:Area/France/Extraction">000199</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study</title><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Clinical Neurosciences, Institute of Neurology, University College London, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Albrecht, Stefan" sort="Albrecht, Stefan" uniqKey="Albrecht S" first="Stefan" last="Albrecht">Stefan Albrecht</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim GmbH, CD Medical Affairs CNS, Ingelheim</wicri:regionArea><wicri:noRegion>Ingelheim</wicri:noRegion><wicri:noRegion>Ingelheim</wicri:noRegion></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples</wicri:regionArea><wicri:noRegion>Naples</wicri:noRegion></affiliation></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Mcdermott, Michael P" sort="Mcdermott, Michael P" uniqKey="Mcdermott M" first="Michael P." last="Mcdermott">Michael P. Mcdermott</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation wicri:level="3"><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo</wicri:regionArea><placeName><settlement type="city">Tokyo</settlement></placeName></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Innsbruck Medical University, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, Clinical Investigation Center INSERM CIC9302 and INSERM UMR825, Toulouse University Hospital, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Marek, Kenneth" sort="Marek, Kenneth" uniqKey="Marek K" first="Kenneth" last="Marek">Kenneth Marek</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Institute for Neurodegenerative Disorders, New Haven, Connecticut</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-08-15">2010-08-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1627">1627</biblScope><biblScope unit="page" to="1632">1632</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">7B5F1EFF37468DE770370D07C19C11E1F8E02073</idno><idno type="DOI">10.1002/mds.23143</idno><idno type="ArticleID">MDS23143</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Benzothiazoles (administration & dosage)</term><term>Double-Blind Method</term><term>Drug Delivery Systems (methods)</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Pain Measurement</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Pramipexole</term><term>Quality of Life</term><term>Severity of Illness Index</term><term>clinical trial</term><term>delayed‐start</term><term>neuroprotection</term><term>pramipexole</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Delivery Systems</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Quality of Life</term><term>Severity of Illness Index</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Pramipexole</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><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. © 2010 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>France</li><li>Italie</li><li>Japon</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Connecticut</li><li>Grand Londres</li><li>Illinois</li><li>Midi-Pyrénées</li><li>Tyrol (Land)</li><li>État de New York</li></region><settlement><li>Innsbruck</li><li>Londres</li><li>Tokyo</li><li>Toulouse</li></settlement><orgName><li>Université Toulouse III - Paul Sabatier</li><li>Université de Toulouse</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name></region></country><country name="Allemagne"><noRegion><name sortKey="Albrecht, Stefan" sort="Albrecht, Stefan" uniqKey="Albrecht S" first="Stefan" last="Albrecht">Stefan Albrecht</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name></noRegion></country><country name="États-Unis"><region name="Illinois"><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name></region><name sortKey="Marek, Kenneth" sort="Marek, Kenneth" uniqKey="Marek K" first="Kenneth" last="Marek">Kenneth Marek</name><name sortKey="Mcdermott, Michael P" sort="Mcdermott, Michael P" uniqKey="Mcdermott M" first="Michael P." last="Mcdermott">Michael P. Mcdermott</name></country><country name="Japon"><noRegion><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name></noRegion></country><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></region></country><country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/France/Analysis
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000199 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/France/Analysis/biblio.hfd -nk 000199 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= France
|étape= Analysis
|type= RBID
|clé= ISTEX:7B5F1EFF37468DE770370D07C19C11E1F8E02073
|texte= Rationale for delayed‐start study of pramipexole in Parkinson's disease: The PROUD study
}}
| This area was generated with Dilib version V0.6.23. |  |