Movement Disorders (revue)

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Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease

Identifieur interne : 000B62 ( PascalFrancis/Corpus ); précédent : 000B61; suivant : 000B63

Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease

Auteurs : Juliana Bronzova ; Cristina Sampaio ; Robert A. Hauser ; Anthony E. Lang ; Olivier Rascol ; Ad Theeuwes ; Serge V. Van De Witte ; Guus Van Scharrenburg

Source :

RBID : Pascal:10-0233116

Descripteurs français

English descriptors

Abstract

This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
A01 01  1    @0 0885-3185
A03   1    @0 Mov. disord.
A05       @2 25
A06       @2 6
A08 01  1  ENG  @1 Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease
A11 01  1    @1 BRONZOVA (Juliana)
A11 02  1    @1 SAMPAIO (Cristina)
A11 03  1    @1 HAUSER (Robert A.)
A11 04  1    @1 LANG (Anthony E.)
A11 05  1    @1 RASCOL (Olivier)
A11 06  1    @1 THEEUWES (Ad)
A11 07  1    @1 VAN DE WITTE (Serge V.)
A11 08  1    @1 VAN SCHARRENBURG (Guus)
A14 01      @1 Solvay Pharmaceuticals B.V., Clinical Neuroscience Department @2 Weesp @3 NLD @Z 1 aut. @Z 6 aut. @Z 7 aut. @Z 8 aut.
A14 02      @1 Department of Pharmacology, Faculdade de Medicina de Lisboa @2 Lisbon @3 PRT @Z 2 aut.
A14 03      @1 Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida @2 Tampa, Florida @3 USA @Z 3 aut.
A14 04      @1 Division of Neurology, Toronto Western Hospital, University of Toronto @2 Toronto, Ontario @3 CAN @Z 4 aut.
A14 05      @1 Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825 @2 Toulouse @3 FRA @Z 5 aut.
A20       @1 738-746
A21       @1 2010
A23 01      @0 ENG
A43 01      @1 INIST @2 20953 @5 354000181078480110
A44       @0 0000 @1 © 2010 INIST-CNRS. All rights reserved.
A45       @0 34 ref.
A47 01  1    @0 10-0233116
A60       @1 P
A61       @0 A
A64 01  1    @0 Movement disorders
A66 01      @0 USA
C01 01    ENG  @0 This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.
C02 01  X    @0 002B17
C02 02  X    @0 002B17G
C03 01  X  FRE  @0 Maladie de Parkinson @2 NM @5 01
C03 01  X  ENG  @0 Parkinson disease @2 NM @5 01
C03 01  X  SPA  @0 Parkinson enfermedad @2 NM @5 01
C03 02  X  FRE  @0 Pathologie du système nerveux @5 02
C03 02  X  ENG  @0 Nervous system diseases @5 02
C03 02  X  SPA  @0 Sistema nervioso patología @5 02
C03 03  X  FRE  @0 Etude double insu @5 09
C03 03  X  ENG  @0 Double blind study @5 09
C03 03  X  SPA  @0 Estudio doble ciego @5 09
C03 04  X  FRE  @0 Pardoprunox @2 FR @5 10
C03 04  X  ENG  @0 Pardoprunox @2 FR @5 10
C03 04  X  SPA  @0 Pardoprunox @2 FR @5 10
C03 05  X  FRE  @0 Agoniste partiel @5 11
C03 05  X  ENG  @0 Partial agonist @5 11
C03 05  X  SPA  @0 Agonista parcial @5 11
C03 06  X  FRE  @0 Stimulant dopaminergique @5 12
C03 06  X  ENG  @0 Dopamine agonist @5 12
C03 06  X  SPA  @0 Estimulante dopaminérgico @5 12
C03 07  X  FRE  @0 Essai clinique @5 13
C03 07  X  ENG  @0 Clinical trial @5 13
C03 07  X  SPA  @0 Ensayo clínico @5 13
C07 01  X  FRE  @0 Pathologie de l'encéphale @5 37
C07 01  X  ENG  @0 Cerebral disorder @5 37
C07 01  X  SPA  @0 Encéfalo patología @5 37
C07 02  X  FRE  @0 Syndrome extrapyramidal @5 38
C07 02  X  ENG  @0 Extrapyramidal syndrome @5 38
C07 02  X  SPA  @0 Extrapiramidal síndrome @5 38
C07 03  X  FRE  @0 Maladie dégénérative @5 39
C07 03  X  ENG  @0 Degenerative disease @5 39
C07 03  X  SPA  @0 Enfermedad degenerativa @5 39
C07 04  X  FRE  @0 Pathologie du système nerveux central @5 40
C07 04  X  ENG  @0 Central nervous system disease @5 40
C07 04  X  SPA  @0 Sistema nervosio central patología @5 40
N21       @1 158
N44 01      @1 OTO
N82       @1 OTO

Format Inist (serveur)

NO : PASCAL 10-0233116 INIST
ET : Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease
AU : BRONZOVA (Juliana); SAMPAIO (Cristina); HAUSER (Robert A.); LANG (Anthony E.); RASCOL (Olivier); THEEUWES (Ad); VAN DE WITTE (Serge V.); VAN SCHARRENBURG (Guus)
AF : Solvay Pharmaceuticals B.V., Clinical Neuroscience Department/Weesp/Pays-Bas (1 aut., 6 aut., 7 aut., 8 aut.); Department of Pharmacology, Faculdade de Medicina de Lisboa/Lisbon/Portugal (2 aut.); Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida/Tampa, Florida/Etats-Unis (3 aut.); Division of Neurology, Toronto Western Hospital, University of Toronto/Toronto, Ontario/Canada (4 aut.); Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825/Toulouse/France (5 aut.)
DT : Publication en série; Niveau analytique
SO : Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2010; Vol. 25; No. 6; Pp. 738-746; Bibl. 34 ref.
LA : Anglais
EA : This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.
CC : 002B17; 002B17G
FD : Maladie de Parkinson; Pathologie du système nerveux; Etude double insu; Pardoprunox; Agoniste partiel; Stimulant dopaminergique; Essai clinique
FG : Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central
ED : Parkinson disease; Nervous system diseases; Double blind study; Pardoprunox; Partial agonist; Dopamine agonist; Clinical trial
EG : Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD : Parkinson enfermedad; Sistema nervioso patología; Estudio doble ciego; Pardoprunox; Agonista parcial; Estimulante dopaminérgico; Ensayo clínico
LO : INIST-20953.354000181078480110
ID : 10-0233116

Links to Exploration step

Pascal:10-0233116

Le document en format XML

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<div type="abstract" xml:lang="en">This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.</div>
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<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="02">
<s1>Department of Pharmacology, Faculdade de Medicina de Lisboa</s1>
<s2>Lisbon</s2>
<s3>PRT</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida</s1>
<s2>Tampa, Florida</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04">
<s1>Division of Neurology, Toronto Western Hospital, University of Toronto</s1>
<s2>Toronto, Ontario</s2>
<s3>CAN</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05">
<s1>Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA20>
<s1>738-746</s1>
</fA20>
<fA21>
<s1>2010</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
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<s1>INIST</s1>
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<s5>354000181078480110</s5>
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<fA44>
<s0>0000</s0>
<s1>© 2010 INIST-CNRS. All rights reserved.</s1>
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<fA45>
<s0>34 ref.</s0>
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<s0>10-0233116</s0>
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<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
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<fA64 i1="01" i2="1">
<s0>Movement disorders</s0>
</fA64>
<fA66 i1="01">
<s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B17G</s0>
</fC02>
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<s0>Maladie de Parkinson</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Parkinson disease</s0>
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<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>Etude double insu</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Double blind study</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Estudio doble ciego</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Pardoprunox</s0>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Pardoprunox</s0>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Pardoprunox</s0>
<s2>FR</s2>
<s5>10</s5>
</fC03>
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<s0>Agoniste partiel</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Partial agonist</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Agonista parcial</s0>
<s5>11</s5>
</fC03>
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<s0>Stimulant dopaminergique</s0>
<s5>12</s5>
</fC03>
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<s0>Dopamine agonist</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Estimulante dopaminérgico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>13</s5>
</fC03>
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<s0>Ensayo clínico</s0>
<s5>13</s5>
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<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>158</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
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<server>
<NO>PASCAL 10-0233116 INIST</NO>
<ET>Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease</ET>
<AU>BRONZOVA (Juliana); SAMPAIO (Cristina); HAUSER (Robert A.); LANG (Anthony E.); RASCOL (Olivier); THEEUWES (Ad); VAN DE WITTE (Serge V.); VAN SCHARRENBURG (Guus)</AU>
<AF>Solvay Pharmaceuticals B.V., Clinical Neuroscience Department/Weesp/Pays-Bas (1 aut., 6 aut., 7 aut., 8 aut.); Department of Pharmacology, Faculdade de Medicina de Lisboa/Lisbon/Portugal (2 aut.); Departments of Neurology, Pharmacology and Experimental Therapeutics, University of South Florida/Tampa, Florida/Etats-Unis (3 aut.); Division of Neurology, Toronto Western Hospital, University of Toronto/Toronto, Ontario/Canada (4 aut.); Departments of Neurosciences and Clinical Pharmacology, Clinical Investigation Center, University Hospital of Toulouse, INSERM UMR 825/Toulouse/France (5 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2010; Vol. 25; No. 6; Pp. 738-746; Bibl. 34 ref.</SO>
<LA>Anglais</LA>
<EA>This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du système nerveux; Etude double insu; Pardoprunox; Agoniste partiel; Stimulant dopaminergique; Essai clinique</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; Double blind study; Pardoprunox; Partial agonist; Dopamine agonist; Clinical trial</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Estudio doble ciego; Pardoprunox; Agonista parcial; Estimulante dopaminérgico; Ensayo clínico</SD>
<LO>INIST-20953.354000181078480110</LO>
<ID>10-0233116</ID>
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