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 : 000585 ( PascalFrancis/Corpus ); précédent : 000584; suivant : 000586A 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 ; Robert A. Hauser ; Joseph Jankovic ; William Langston ; Anthony Lang ; Wemer Poewe ; Eduardo Tolosa ; Fabrizio Stocchi ; Eldad Melamed ; Eli Eyal ; Olivier RascolSource :
- 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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Format Inist (serveur)
NO : | PASCAL 09-0038011 INIST |
---|---|
ET : | 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 |
AU : | OLANOW (C. Warren); HAUSER (Robert A.); JANKOVIC (Joseph); LANGSTON (William); LANG (Anthony); POEWE (Wemer); TOLOSA (Eduardo); STOCCHI (Fabrizio); MELAMED (Eldad); EYAL (Eli); RASCOL (Olivier) |
AF : | Department of Neurology, Mount Sinai School of Medicine/New York, New York/Etats-Unis (1 aut.); Parkinson's Disease and Movement Disorders Center, University of South Florida/Tampa, Florida/Etats-Unis (2 aut.); Department of Neurology, Baylor College of Medicine/Houston, Texas/Etats-Unis (3 aut.); The Parkinson's Institute/Sunnyvale, California/Etats-Unis (4 aut.); Department of Neurology, Toronto Western Hospital/Toronto, Ontario/Canada (5 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (6 aut.); Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona/Espagne (7 aut.); Institute of Neurology, IRCCS San Raffaele Pisana/Rome/Italie (8 aut.); Department of Neurology, Rabin Medical Center, Beilinson campus. Petah Tikva and Sackler, School of Medicine, Tel Aviv University/Israël (9 aut.); Global Statistics Unit, Teva Pharmaceutical Industries Ltd/Israël (10 aut.); INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Me'decine/Toulouse/France (11 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2008; Vol. 23; No. 15; Pp. 2194-2201; Bibl. 56 ref. |
LA : | Anglais |
EA : | 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. |
CC : | 002B17; 002B17G |
FD : | Maladie de Parkinson; Pathologie du système nerveux; Placebo; Rasagiline; Traitement; Modification |
FG : | Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central |
ED : | Parkinson disease; Nervous system diseases; Placebo; Rasagiline; Treatment; Modification |
EG : | Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease |
SD : | Parkinson enfermedad; Sistema nervioso patología; Placebo; Rasagilina; Tratamiento; Modificación |
LO : | INIST-20953.354000185020710080 |
ID : | 09-0038011 |
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Pascal:09-0038011Le document en format XML
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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>
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<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>
<server><NO>PASCAL 09-0038011 INIST</NO>
<ET>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</ET>
<AU>OLANOW (C. Warren); HAUSER (Robert A.); JANKOVIC (Joseph); LANGSTON (William); LANG (Anthony); POEWE (Wemer); TOLOSA (Eduardo); STOCCHI (Fabrizio); MELAMED (Eldad); EYAL (Eli); RASCOL (Olivier)</AU>
<AF>Department of Neurology, Mount Sinai School of Medicine/New York, New York/Etats-Unis (1 aut.); Parkinson's Disease and Movement Disorders Center, University of South Florida/Tampa, Florida/Etats-Unis (2 aut.); Department of Neurology, Baylor College of Medicine/Houston, Texas/Etats-Unis (3 aut.); The Parkinson's Institute/Sunnyvale, California/Etats-Unis (4 aut.); Department of Neurology, Toronto Western Hospital/Toronto, Ontario/Canada (5 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (6 aut.); Movement Disorder Unit, Neurology Service, Hospital Clinic, University of Barcelona/Espagne (7 aut.); Institute of Neurology, IRCCS San Raffaele Pisana/Rome/Italie (8 aut.); Department of Neurology, Rabin Medical Center, Beilinson campus. Petah Tikva and Sackler, School of Medicine, Tel Aviv University/Israël (9 aut.); Global Statistics Unit, Teva Pharmaceutical Industries Ltd/Israël (10 aut.); INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Me'decine/Toulouse/France (11 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2008; Vol. 23; No. 15; Pp. 2194-2201; Bibl. 56 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du système nerveux; Placebo; Rasagiline; Traitement; Modification</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; Placebo; Rasagiline; Treatment; Modification</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Placebo; Rasagilina; Tratamiento; Modificación</SD>
<LO>INIST-20953.354000185020710080</LO>
<ID>09-0038011</ID>
</server>
</inist>
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