Movement Disorders (revue)

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Placebo Influences on Dyskinesia in Parkinson's Disease

Identifieur interne : 001284 ( PascalFrancis/Corpus ); précédent : 001283; suivant : 001285

Placebo Influences on Dyskinesia in Parkinson's Disease

Auteurs : Christopher G. Goetz ; Eugene Laska ; Christine Hicking ; Philippe Damier ; Thomas Müller ; John Nutt ; C. Warren Olanow ; Olivier Rascol ; Hermann Russ

Source :

RBID : Pascal:08-0247739

Descripteurs français

English descriptors

Abstract

Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson disease patients were determined. Placebo-associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo-related dyskinesia improvements and worsening. Because placebo-associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty-four subjects received placebo treatment; 178 met criteria for placebo-associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo-associated improvement, whereas lower baseline dyskinesia score was associated with placebo-associated worsening. Placebo-associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo-effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo-induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo-associated improvements in dyskinesia. The magnitude and variance of placebo-related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08 01  1  ENG  @1 Placebo Influences on Dyskinesia in Parkinson's Disease
A11 01  1    @1 GOETZ (Christopher G.)
A11 02  1    @1 LASKA (Eugene)
A11 03  1    @1 HICKING (Christine)
A11 04  1    @1 DAMIER (Philippe)
A11 05  1    @1 MÜLLER (Thomas)
A11 06  1    @1 NUTT (John)
A11 07  1    @1 OLANOW (C. Warren)
A11 08  1    @1 RASCOL (Olivier)
A11 09  1    @1 RUSS (Hermann)
A14 01      @1 Rush University Medical Center @2 Chicago, Illinois @3 USA @Z 1 aut.
A14 02      @1 New York University School of Medicine @2 New York, New York @3 USA @Z 2 aut.
A14 03      @1 Nathan Kline Institute @2 Orangeburg, New York @3 USA @Z 2 aut.
A14 04      @1 Merck KGaA @2 Darmstadt @3 DEU @Z 3 aut. @Z 9 aut.
A14 05      @1 Centre Hospitalo-universitaire de Nantes, Centre d'Investigation Clinique @2 Nantes @3 FRA @Z 4 aut.
A14 06      @1 Ruhr University @2 Bochum @3 DEU @Z 5 aut.
A14 07      @1 Oregon Health Sciences University @2 Portland, Oregon @3 USA @Z 6 aut.
A14 08      @1 Mount Sinai School of Medicine New York @2 New York @3 USA @Z 7 aut.
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C01 01    ENG  @0 Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson disease patients were determined. Placebo-associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo-related dyskinesia improvements and worsening. Because placebo-associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty-four subjects received placebo treatment; 178 met criteria for placebo-associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo-associated improvement, whereas lower baseline dyskinesia score was associated with placebo-associated worsening. Placebo-associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo-effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo-induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo-associated improvements in dyskinesia. The magnitude and variance of placebo-related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents.
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C03 01  X  ENG  @0 Dyskinesia @5 01
C03 01  X  SPA  @0 Disquinesia @5 01
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C03 05  X  SPA  @0 Sarizotán @2 NK @2 FR @5 10
C03 06  X  FRE  @0 Essai clinique @5 11
C03 06  X  ENG  @0 Clinical trial @5 11
C03 06  X  SPA  @0 Ensayo clínico @5 11
C07 01  X  FRE  @0 Syndrome extrapyramidal @5 37
C07 01  X  ENG  @0 Extrapyramidal syndrome @5 37
C07 01  X  SPA  @0 Extrapiramidal síndrome @5 37
C07 02  X  FRE  @0 Mouvement involontaire @5 38
C07 02  X  ENG  @0 Involuntary movement @5 38
C07 02  X  SPA  @0 Movimiento involuntario @5 38
C07 03  X  FRE  @0 Trouble neurologique @5 40
C07 03  X  ENG  @0 Neurological disorder @5 40
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Format Inist (serveur)

NO : PASCAL 08-0247739 INIST
ET : Placebo Influences on Dyskinesia in Parkinson's Disease
AU : GOETZ (Christopher G.); LASKA (Eugene); HICKING (Christine); DAMIER (Philippe); MÜLLER (Thomas); NUTT (John); OLANOW (C. Warren); RASCOL (Olivier); RUSS (Hermann)
AF : Rush University Medical Center/Chicago, Illinois/Etats-Unis (1 aut.); New York University School of Medicine/New York, New York/Etats-Unis (2 aut.); Nathan Kline Institute/Orangeburg, New York/Etats-Unis (2 aut.); Merck KGaA/Darmstadt/Allemagne (3 aut., 9 aut.); Centre Hospitalo-universitaire de Nantes, Centre d'Investigation Clinique/Nantes/France (4 aut.); Ruhr University/Bochum/Allemagne (5 aut.); Oregon Health Sciences University/Portland, Oregon/Etats-Unis (6 aut.); Mount Sinai School of Medicine New York/New York/Etats-Unis (7 aut.); Toulouse University Hospital, INSERM Clinical Investigation Center/Toulouse/France (8 aut.)
DT : Publication en série; Niveau analytique
SO : Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2008; Vol. 23; No. 5; Pp. 700-707; Bibl. 21 ref.
LA : Anglais
EA : Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson disease patients were determined. Placebo-associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo-related dyskinesia improvements and worsening. Because placebo-associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty-four subjects received placebo treatment; 178 met criteria for placebo-associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo-associated improvement, whereas lower baseline dyskinesia score was associated with placebo-associated worsening. Placebo-associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo-effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo-induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo-associated improvements in dyskinesia. The magnitude and variance of placebo-related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents.
CC : 002B17; 002B17G
FD : Dyskinésie; Maladie de Parkinson; Pathologie du système nerveux; Placebo; Sarizotan; Essai clinique
FG : Syndrome extrapyramidal; Mouvement involontaire; Trouble neurologique; Pathologie de l'encéphale; Maladie dégénérative; Pathologie du système nerveux central
ED : Dyskinesia; Parkinson disease; Nervous system diseases; Placebo; Sarizotan; Clinical trial
EG : Extrapyramidal syndrome; Involuntary movement; Neurological disorder; Cerebral disorder; Degenerative disease; Central nervous system disease
SD : Disquinesia; Parkinson enfermedad; Sistema nervioso patología; Placebo; Sarizotán; Ensayo clínico
LO : INIST-20953.354000173776990100
ID : 08-0247739

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Pascal:08-0247739

Le document en format XML

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<div type="abstract" xml:lang="en">Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson disease patients were determined. Placebo-associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo-related dyskinesia improvements and worsening. Because placebo-associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty-four subjects received placebo treatment; 178 met criteria for placebo-associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo-associated improvement, whereas lower baseline dyskinesia score was associated with placebo-associated worsening. Placebo-associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo-effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo-induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo-associated improvements in dyskinesia. The magnitude and variance of placebo-related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents.</div>
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<fA14 i1="02">
<s1>New York University School of Medicine</s1>
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<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Nathan Kline Institute</s1>
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</fA14>
<fA14 i1="04">
<s1>Merck KGaA</s1>
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<sZ>9 aut.</sZ>
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<s1>Centre Hospitalo-universitaire de Nantes, Centre d'Investigation Clinique</s1>
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</fA14>
<fA14 i1="06">
<s1>Ruhr University</s1>
<s2>Bochum</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="07">
<s1>Oregon Health Sciences University</s1>
<s2>Portland, Oregon</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
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<fA14 i1="08">
<s1>Mount Sinai School of Medicine New York</s1>
<s2>New York</s2>
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<sZ>7 aut.</sZ>
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<fA14 i1="09">
<s1>Toulouse University Hospital, INSERM Clinical Investigation Center</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
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<fA20>
<s1>700-707</s1>
</fA20>
<fA21>
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<s0>Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson disease patients were determined. Placebo-associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo-related dyskinesia improvements and worsening. Because placebo-associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty-four subjects received placebo treatment; 178 met criteria for placebo-associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo-associated improvement, whereas lower baseline dyskinesia score was associated with placebo-associated worsening. Placebo-associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo-effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo-induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo-associated improvements in dyskinesia. The magnitude and variance of placebo-related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents.</s0>
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<s2>FR</s2>
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<s5>38</s5>
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<fC07 i1="03" i2="X" l="SPA">
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<s5>40</s5>
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<fC07 i1="04" i2="X" l="FRE">
<s0>Pathologie de l'encéphale</s0>
<s5>41</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Cerebral disorder</s0>
<s5>41</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
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<s5>41</s5>
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<s0>Maladie dégénérative</s0>
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<fC07 i1="05" i2="X" l="ENG">
<s0>Degenerative disease</s0>
<s5>42</s5>
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<fC07 i1="05" i2="X" l="SPA">
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<s5>42</s5>
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<NO>PASCAL 08-0247739 INIST</NO>
<ET>Placebo Influences on Dyskinesia in Parkinson's Disease</ET>
<AU>GOETZ (Christopher G.); LASKA (Eugene); HICKING (Christine); DAMIER (Philippe); MÜLLER (Thomas); NUTT (John); OLANOW (C. Warren); RASCOL (Olivier); RUSS (Hermann)</AU>
<AF>Rush University Medical Center/Chicago, Illinois/Etats-Unis (1 aut.); New York University School of Medicine/New York, New York/Etats-Unis (2 aut.); Nathan Kline Institute/Orangeburg, New York/Etats-Unis (2 aut.); Merck KGaA/Darmstadt/Allemagne (3 aut., 9 aut.); Centre Hospitalo-universitaire de Nantes, Centre d'Investigation Clinique/Nantes/France (4 aut.); Ruhr University/Bochum/Allemagne (5 aut.); Oregon Health Sciences University/Portland, Oregon/Etats-Unis (6 aut.); Mount Sinai School of Medicine New York/New York/Etats-Unis (7 aut.); Toulouse University Hospital, INSERM Clinical Investigation Center/Toulouse/France (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2008; Vol. 23; No. 5; Pp. 700-707; Bibl. 21 ref.</SO>
<LA>Anglais</LA>
<EA>Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson disease patients were determined. Placebo-associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo-related dyskinesia improvements and worsening. Because placebo-associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty-four subjects received placebo treatment; 178 met criteria for placebo-associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo-associated improvement, whereas lower baseline dyskinesia score was associated with placebo-associated worsening. Placebo-associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo-effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo-induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo-associated improvements in dyskinesia. The magnitude and variance of placebo-related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents.</EA>
<CC>002B17; 002B17G</CC>
<FD>Dyskinésie; Maladie de Parkinson; Pathologie du système nerveux; Placebo; Sarizotan; Essai clinique</FD>
<FG>Syndrome extrapyramidal; Mouvement involontaire; Trouble neurologique; Pathologie de l'encéphale; Maladie dégénérative; Pathologie du système nerveux central</FG>
<ED>Dyskinesia; Parkinson disease; Nervous system diseases; Placebo; Sarizotan; Clinical trial</ED>
<EG>Extrapyramidal syndrome; Involuntary movement; Neurological disorder; Cerebral disorder; Degenerative disease; Central nervous system disease</EG>
<SD>Disquinesia; Parkinson enfermedad; Sistema nervioso patología; Placebo; Sarizotán; Ensayo clínico</SD>
<LO>INIST-20953.354000173776990100</LO>
<ID>08-0247739</ID>
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