Movement Disorders (revue)

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A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease.

Identifieur interne : 001B12 ( Ncbi/Curation ); précédent : 001B11; suivant : 001B13

A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease.

Auteurs : Carlos Singer [États-Unis] ; Janice Lamb ; Amanda Ellis ; Gary Layton

Source :

RBID : pubmed:17318839

English descriptors

Abstract

To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P
DOI: 10.1002/mds.21361
PubMed: 17318839

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<nlm:affiliation>Department of Neurology, University of Miami, Miami, Florida, USA. csinger@med.miami.edu</nlm:affiliation>
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<div type="abstract" xml:lang="en">To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P </div>
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