MovDisordV3, PascalFrancis, Corpus, bibRecord, 001756

Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease

Identifieur interne : 001756 ( PascalFrancis/Corpus ); précédent : 001755; suivant : 001757

Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease

Auteurs : Paolo Barone ; Janice Lamb ; Amanda Ellis ; Zoe Clarke

Source :

Movement disorders [ 0885-3185 ] ; 2007.

RBID : Pascal:07-0210946

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Parkinson maladie, Sumanirole, Etude comparative, Placebo, Ropinirole, Traitement, Homme, Stade avancé, Stimulant dopaminergique, Lévodopa.

English descriptors

KwdEn :
- Advanced stage, Comparative study, Dopamine agonist, Human, Levodopa, Nervous system diseases, Parkinson disease, Placebo, Ropinirole, Sumanirole, Treatment.

Abstract

The aims of this study were to assess the safety, tolerability, and efficacy of sumanirole, a highly selective D₂ dopamine receptor agonist, versus placebo in subjects with advanced Parkinson's disease (PD), and to demonstrate noninferiority of sumanirole to ropinirole. In this flexible-dose, randomized, double-blind, double-dummy, parallel-group study, 948 subjects were treated with sumanirole 1 to 48 mg/day, ropinirole 0.75 to 24 mg/day, or placebo. Treatment consisted of 13 weeks of dose escalation, 26 weeks of maintenance, and 1 week of tapering. Approximately 70% of subjects treated with either sumanirole or ropinirole completed the study. Statistical significance (P < 0.0001) was achieved when both sumanirole and ropinirole groups were compared with placebo, with mean differences of -7.7 and -8.8 on combined sum of the Unified Parkinson's Disease Rating Scale (UPDRS) part II (average on and off) and part III total scores at the end of maintenance. Noninferiority of sumanirole to ropinirole was also demonstrated, with a sumanirole minus ropinirole difference of 1.17 (90% CI: -0.56 to 2.89). Both dopamine agonists, sumanirole and ropinirole, were statistically superior compared with placebo as adjunctive therapy for patients with advanced Parkinson's disease, based on UPDRS II + III total score. Noninferiority of sumanirole to ropinirole was established, with comparable tolerability profiles.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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Format Inist (serveur)

NO :	PASCAL 07-0210946 INIST
ET :	Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease
AU :	BARONE (Paolo); LAMB (Janice); ELLIS (Amanda); CLARKE (Zoe)
AF :	Department of Neurological Sciences, University "Federico II"/Napoli/Italie (1 aut.); Pfizer Global Research and Development/Sandwich, Kent/Royaume-Uni (2 aut., 3 aut., 4 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 4; Pp. 483-489; Bibl. 22 ref.
LA :	Anglais
EA :	The aims of this study were to assess the safety, tolerability, and efficacy of sumanirole, a highly selective D₂ dopamine receptor agonist, versus placebo in subjects with advanced Parkinson's disease (PD), and to demonstrate noninferiority of sumanirole to ropinirole. In this flexible-dose, randomized, double-blind, double-dummy, parallel-group study, 948 subjects were treated with sumanirole 1 to 48 mg/day, ropinirole 0.75 to 24 mg/day, or placebo. Treatment consisted of 13 weeks of dose escalation, 26 weeks of maintenance, and 1 week of tapering. Approximately 70% of subjects treated with either sumanirole or ropinirole completed the study. Statistical significance (P < 0.0001) was achieved when both sumanirole and ropinirole groups were compared with placebo, with mean differences of -7.7 and -8.8 on combined sum of the Unified Parkinson's Disease Rating Scale (UPDRS) part II (average on and off) and part III total scores at the end of maintenance. Noninferiority of sumanirole to ropinirole was also demonstrated, with a sumanirole minus ropinirole difference of 1.17 (90% CI: -0.56 to 2.89). Both dopamine agonists, sumanirole and ropinirole, were statistically superior compared with placebo as adjunctive therapy for patients with advanced Parkinson's disease, based on UPDRS II + III total score. Noninferiority of sumanirole to ropinirole was established, with comparable tolerability profiles.
CC :	002B17; 002B17G; 002B17F
FD :	Système nerveux pathologie; Parkinson maladie; Sumanirole; Etude comparative; Placebo; Ropinirole; Traitement; Homme; Stade avancé; Stimulant dopaminergique; Lévodopa
FG :	Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie
ED :	Nervous system diseases; Parkinson disease; Sumanirole; Comparative study; Placebo; Ropinirole; Treatment; Human; Advanced stage; Dopamine agonist; Levodopa
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Sistema nervioso patología; Parkinson enfermedad; Sumanirol; Estudio comparativo; Placebo; Ropinirol; Tratamiento; Hombre; Estadio avanzado; Estimulante dopaminérgico; Levodopa
LO :	INIST-20953.354000145702210050
ID :	07-0210946

Links to Exploration step

Pascal:07-0210946

Le document en format XML

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<front><div type="abstract" xml:lang="en">The aims of this study were to assess the safety, tolerability, and efficacy of sumanirole, a highly selective D<sub>2</sub>
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<s5>10</s5>
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<fC03 i1="04" i2="X" l="SPA"><s0>Estudio comparativo</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Placebo</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Placebo</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Placebo</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Ropinirole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Ropinirole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Ropinirol</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Traitement</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Treatment</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Homme</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Human</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Hombre</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Stade avancé</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Advanced stage</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Estadio avanzado</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Stimulant dopaminergique</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Dopamine agonist</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Estimulante dopaminérgico</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>17</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Encéphale pathologie</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>Extrapyramidal syndrome</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>Système nerveux central pathologie</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>141</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 07-0210946 INIST</NO>
<ET>Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease</ET>
<AU>BARONE (Paolo); LAMB (Janice); ELLIS (Amanda); CLARKE (Zoe)</AU>
<AF>Department of Neurological Sciences, University "Federico II"/Napoli/Italie (1 aut.); Pfizer Global Research and Development/Sandwich, Kent/Royaume-Uni (2 aut., 3 aut., 4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 4; Pp. 483-489; Bibl. 22 ref.</SO>
<LA>Anglais</LA>
<EA>The aims of this study were to assess the safety, tolerability, and efficacy of sumanirole, a highly selective D<sub>2</sub>
 dopamine receptor agonist, versus placebo in subjects with advanced Parkinson's disease (PD), and to demonstrate noninferiority of sumanirole to ropinirole. In this flexible-dose, randomized, double-blind, double-dummy, parallel-group study, 948 subjects were treated with sumanirole 1 to 48 mg/day, ropinirole 0.75 to 24 mg/day, or placebo. Treatment consisted of 13 weeks of dose escalation, 26 weeks of maintenance, and 1 week of tapering. Approximately 70% of subjects treated with either sumanirole or ropinirole completed the study. Statistical significance (P < 0.0001) was achieved when both sumanirole and ropinirole groups were compared with placebo, with mean differences of -7.7 and -8.8 on combined sum of the Unified Parkinson's Disease Rating Scale (UPDRS) part II (average on and off) and part III total scores at the end of maintenance. Noninferiority of sumanirole to ropinirole was also demonstrated, with a sumanirole minus ropinirole difference of 1.17 (90% CI: -0.56 to 2.89). Both dopamine agonists, sumanirole and ropinirole, were statistically superior compared with placebo as adjunctive therapy for patients with advanced Parkinson's disease, based on UPDRS II + III total score. Noninferiority of sumanirole to ropinirole was established, with comparable tolerability profiles.</EA>
<CC>002B17; 002B17G; 002B17F</CC>
<FD>Système nerveux pathologie; Parkinson maladie; Sumanirole; Etude comparative; Placebo; Ropinirole; Traitement; Homme; Stade avancé; Stimulant dopaminergique; Lévodopa</FD>
<FG>Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie</FG>
<ED>Nervous system diseases; Parkinson disease; Sumanirole; Comparative study; Placebo; Ropinirole; Treatment; Human; Advanced stage; Dopamine agonist; Levodopa</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Sistema nervioso patología; Parkinson enfermedad; Sumanirol; Estudio comparativo; Placebo; Ropinirol; Tratamiento; Hombre; Estadio avanzado; Estimulante dopaminérgico; Levodopa</SD>
<LO>INIST-20953.354000145702210050</LO>
<ID>07-0210946</ID>
</server>
</inist>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease

Sumanirole versus placebo or ropinirole for the adjunctive treatment of patients with advanced Parkinson's disease

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