A Randomized, Double-Blind, Placebo-Controlled, Delayed Start Study to Assess Rasagiline as a Disease Modifying Therapy in Parkinson's Disease (The ADAGIO Study) : Rationale, Design, and Baseline Characteristics
Identifieur interne : 003997 ( Main/Merge ); précédent : 003996; suivant : 003998A Randomized, Double-Blind, Placebo-Controlled, Delayed Start Study to Assess Rasagiline as a Disease Modifying Therapy in Parkinson's Disease (The ADAGIO Study) : Rationale, Design, and Baseline Characteristics
Auteurs : C. Warren Olanow [États-Unis] ; Robert A. Hauser [États-Unis] ; Joseph Jankovic [États-Unis] ; William Langston [États-Unis] ; Anthony Lang [Canada] ; Wemer Poewe [Autriche] ; Eduardo Tolosa [Espagne] ; Fabrizio Stocchi [Italie] ; Eldad Melamed [Israël] ; Eli Eyal [Israël] ; Olivier Rascol [France]Source :
- Movement disorders [ 0885-3185 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
Abstract
A neuroprotective therapy is the single most important unmet medical need in Parkinson's disease. Several promising agents in the laboratory have been tested in the clinic, but none has been established in clinical trials to have a disease modifying effect despite positive results because of potential confounding symptomatic or pharmacologic effects. The delayed start design was developed to try to avoid a symptomatic confound when testing a putative neuroprotective therapy. In this study design, patients are randomly assigned to study drug or placebo in the first phase of the study, and both groups receive the active drug in the second phase. If benefits seen at the end of phase I persist through the end of phase II, they cannot be readily explained by a symptomatic effect (as patients in both groups are receiving the same medication) and benefits in the early start group must relate to the early initiation of the treatment. Although the precise mechanism responsible for such an effect can be debated, positive results in a delayed start study indicate that patients who receive early treatment have a better outcome than those where the treatment is delayed. We are using the delayed start design to assess the potential disease modifying effects of rasagiline in a prospective double blind controlled trial (the ADAGIO study). We here describe the rationale for the study and baseline characteristics of the 1,176 patients who have been enrolled into the trial.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">A Randomized, Double-Blind, Placebo-Controlled, Delayed Start Study to Assess Rasagiline as a Disease Modifying Therapy in Parkinson's Disease (The ADAGIO Study) : Rationale, Design, and Baseline Characteristics</title><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Neurology, Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Neurology, Baylor College of Medicine</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Langston, William" sort="Langston, William" uniqKey="Langston W" first="William" last="Langston">William Langston</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>The Parkinson's Institute</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Neurology, Toronto Western Hospital</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>5 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Wemer" sort="Poewe, Wemer" uniqKey="Poewe W" first="Wemer" last="Poewe">Wemer Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, Innsbruck Medical University</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>6 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona</s1><s3>ESP</s3><sZ>7 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Institute of Neurology, IRCCS San Raffaele Pisana</s1><s2>Rome</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Neurology, Rabin Medical Center, Beilinson campus. Petah Tikva and Sackler, School of Medicine, Tel Aviv University</s1><s3>ISR</s3><sZ>9 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Department of Neurology, Rabin Medical Center, Beilinson campus. Petah Tikva and Sackler, School of Medicine, Tel Aviv University</wicri:noRegion></affiliation></author><author><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Global Statistics Unit, Teva Pharmaceutical Industries Ltd</s1><s3>ISR</s3><sZ>10 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Global Statistics Unit, Teva Pharmaceutical Industries Ltd</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Me'decine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><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></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">09-0038011</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 09-0038011 INIST</idno><idno type="RBID">Pascal:09-0038011</idno><idno type="wicri:Area/PascalFrancis/Corpus">001049</idno><idno type="wicri:Area/PascalFrancis/Curation">001C70</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001389</idno><idno type="wicri:doubleKey">0885-3185:2008:Olanow C:a:randomized:double</idno><idno type="wicri:Area/Main/Merge">003997</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A Randomized, Double-Blind, Placebo-Controlled, Delayed Start Study to Assess Rasagiline as a Disease Modifying Therapy in Parkinson's Disease (The ADAGIO Study) : Rationale, Design, and Baseline Characteristics</title><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Neurology, Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Parkinson's Disease and Movement Disorders Center, University of South Florida</s1><s2>Tampa, Florida</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Neurology, Baylor College of Medicine</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Langston, William" sort="Langston, William" uniqKey="Langston W" first="William" last="Langston">William Langston</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>The Parkinson's Institute</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Neurology, Toronto Western Hospital</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>5 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Poewe, Wemer" sort="Poewe, Wemer" uniqKey="Poewe W" first="Wemer" last="Poewe">Wemer Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, Innsbruck Medical University</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>6 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona</s1><s3>ESP</s3><sZ>7 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Institute of Neurology, IRCCS San Raffaele Pisana</s1><s2>Rome</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Neurology, Rabin Medical Center, Beilinson campus. Petah Tikva and Sackler, School of Medicine, Tel Aviv University</s1><s3>ISR</s3><sZ>9 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Department of Neurology, Rabin Medical Center, Beilinson campus. Petah Tikva and Sackler, School of Medicine, Tel Aviv University</wicri:noRegion></affiliation></author><author><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Global Statistics Unit, Teva Pharmaceutical Industries Ltd</s1><s3>ISR</s3><sZ>10 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Global Statistics Unit, Teva Pharmaceutical Industries Ltd</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Me'decine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><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></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Modification</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Placebo</term><term>Rasagiline</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Placebo</term><term>Rasagiline</term><term>Traitement</term><term>Modification</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">A neuroprotective therapy is the single most important unmet medical need in Parkinson's disease. Several promising agents in the laboratory have been tested in the clinic, but none has been established in clinical trials to have a disease modifying effect despite positive results because of potential confounding symptomatic or pharmacologic effects. The delayed start design was developed to try to avoid a symptomatic confound when testing a putative neuroprotective therapy. In this study design, patients are randomly assigned to study drug or placebo in the first phase of the study, and both groups receive the active drug in the second phase. If benefits seen at the end of phase I persist through the end of phase II, they cannot be readily explained by a symptomatic effect (as patients in both groups are receiving the same medication) and benefits in the early start group must relate to the early initiation of the treatment. Although the precise mechanism responsible for such an effect can be debated, positive results in a delayed start study indicate that patients who receive early treatment have a better outcome than those where the treatment is delayed. We are using the delayed start design to assess the potential disease modifying effects of rasagiline in a prospective double blind controlled trial (the ADAGIO study). We here describe the rationale for the study and baseline characteristics of the 1,176 patients who have been enrolled into the trial.</div></front></TEI><affiliations><list><country><li>Autriche</li><li>Canada</li><li>Espagne</li><li>France</li><li>Israël</li><li>Italie</li><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Latium</li><li>Midi-Pyrénées</li><li>Texas</li><li>État de New York</li></region><settlement><li>Houston</li><li>Rome</li><li>Tampa</li><li>Toulouse</li></settlement><orgName><li>Baylor College of Medicine</li><li>Université Toulouse III - Paul Sabatier</li><li>Université de Floride du Sud</li><li>Université de Toulouse</li></orgName></list><tree><country name="États-Unis"><region name="État de New York"><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name></region><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><name sortKey="Langston, William" sort="Langston, William" uniqKey="Langston W" first="William" last="Langston">William Langston</name></country><country name="Canada"><noRegion><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name></noRegion></country><country name="Autriche"><noRegion><name sortKey="Poewe, Wemer" sort="Poewe, Wemer" uniqKey="Poewe W" first="Wemer" last="Poewe">Wemer Poewe</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></noRegion></country><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></region></country><country name="Israël"><noRegion><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name></noRegion><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name></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)
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