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 : 000308 ( France/Analysis ); précédent : 000307; suivant : 000309A 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] ; Werner Poewe [Autriche] ; Eduardo Tolosa [Espagne] ; Fabrizio Stocchi [Italie] ; Eldad Melamed [Israël] ; Eli Eyal [Israël] ; Olivier Rascol [France]Source :
- Movement Disorders [ 0885-3185 ] ; 2008-11-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Indans (therapeutic use), Male, Middle Aged, Modification, Nervous system diseases, Neuroprotective Agents (therapeutic use), Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Placebo, Rasagiline, Retrospective Studies, Treatment, Treatment Outcome, delayed start design, disease modification, neuroprotection, rasagiline.
- MESH :
- chemical , therapeutic use : Indans, Neuroprotective Agents.
- drug therapy : Parkinson Disease.
- Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome.
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. © 2008 Movement Disorder Society
Url:
DOI: 10.1002/mds.22218
Affiliations:
- Autriche, Canada, Espagne, France, Israël, Italie, États-Unis
- Californie, Floride, Latium, Midi-Pyrénées, Texas, Tyrol (Land), État de New York
- Houston, Innsbruck, Rome, Tampa, Toulouse
- Baylor College of Medicine, Université Toulouse III - Paul Sabatier, Université de Floride du Sud, Université de Toulouse, Université de médecine d'Innsbruck
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ISTEX:9028D8D08AB9F4F0E5A22149A3E88C34D86155B2Le document en format XML
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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="2008-11-15">2008-11-15</date><biblScope unit="vol">23</biblScope><biblScope unit="issue">15</biblScope><biblScope unit="page" from="2194">2194</biblScope><biblScope unit="page" to="2201">2201</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">9028D8D08AB9F4F0E5A22149A3E88C34D86155B2</idno><idno type="DOI">10.1002/mds.22218</idno><idno type="ArticleID">MDS22218</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>Aged, 80 and over</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Indans (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Modification</term><term>Nervous system diseases</term><term>Neuroprotective Agents (therapeutic use)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Placebo</term><term>Rasagiline</term><term>Retrospective Studies</term><term>Treatment</term><term>Treatment Outcome</term><term>delayed start design</term><term>disease modification</term><term>neuroprotection</term><term>rasagiline</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Indans</term><term>Neuroprotective Agents</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Retrospective Studies</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Modification</term><term>Pathologie du système nerveux</term><term>Placebo</term><term>Rasagiline</term><term>Traitement</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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. © 2008 Movement Disorder Society</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>Tyrol (Land)</li><li>État de New York</li></region><settlement><li>Houston</li><li>Innsbruck</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><li>Université de médecine d'Innsbruck</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"><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="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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