MovDisordV3, PascalFrancis, Curation, bibRecord, 001C70

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 : 001C70 ( PascalFrancis/Curation ); précédent : 001C69; suivant : 001C71

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

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.

RBID : Pascal:09-0038011

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Placebo, Rasagiline, Traitement, Modification.

English descriptors

KwdEn :
- Modification, Nervous system diseases, Parkinson disease, Placebo, Rasagiline, Treatment.

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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Le document en format XML

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<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
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<author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name>
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<author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name>
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<author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name>
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<author><name sortKey="Eyal, Eli" sort="Eyal, Eli" uniqKey="Eyal E" first="Eli" last="Eyal">Eli Eyal</name>
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<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
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<series><title level="j" type="main">Movement disorders</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Modification</term>
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<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>
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<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>
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<fA11 i1="01" i2="1"><s1>OLANOW (C. Warren)</s1>
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<fA11 i1="02" i2="1"><s1>HAUSER (Robert A.)</s1>
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<fA11 i1="03" i2="1"><s1>JANKOVIC (Joseph)</s1>
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<fA11 i1="09" i2="1"><s1>MELAMED (Eldad)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>EYAL (Eli)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>RASCOL (Olivier)</s1>
</fA11>
<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>
</fA14>
<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>
</fA14>
<fA14 i1="03"><s1>Department of Neurology, Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>The Parkinson's Institute</s1>
<s2>Sunnyvale, California</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Neurology, Toronto Western Hospital</s1>
<s2>Toronto, Ontario</s2>
<s3>CAN</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Department of Neurology, Innsbruck Medical University</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona</s1>
<s3>ESP</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Institute of Neurology, IRCCS San Raffaele Pisana</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>8 aut.</sZ>
</fA14>
<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>
</fA14>
<fA14 i1="10"><s1>Global Statistics Unit, Teva Pharmaceutical Industries Ltd</s1>
<s3>ISR</s3>
<sZ>10 aut.</sZ>
</fA14>
<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>
</fA14>
<fA20><s1>2194-2201</s1>
</fA20>
<fA21><s1>2008</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20953</s2>
<s5>354000185020710080</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2009 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>56 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>09-0038011</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Movement disorders</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B17G</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Maladie de Parkinson</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Pathologie du   système nerveux</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Placebo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Placebo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Placebo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Rasagiline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Rasagiline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Rasagilina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Modification</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Modification</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Modificación</s0>
<s5>12</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</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>Syndrome extrapyramidal</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>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>026</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

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

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

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