Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease
Identifieur interne : 000B62 ( PascalFrancis/Corpus ); précédent : 000B61; suivant : 000B63Double-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 ScharrenburgSource :
- Movement disorders [ 0885-3185 ] ; 2010.
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- Pascal (Inist)
English descriptors
- KwdEn :
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.
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Pour connaître la documentation sur le format Inist Standard.
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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 |
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Pascal:10-0233116Le document en format XML
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<front><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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<s5>13</s5>
</fC03>
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<s5>13</s5>
</fC03>
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<s5>37</s5>
</fC07>
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<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>37</s5>
</fC07>
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<s5>38</s5>
</fC07>
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<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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