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A randomized study of rotigotine dose response on 'off' time in advanced Parkinson's disease.

Identifieur interne : 000448 ( Ncbi/Merge ); précédent : 000447; suivant : 000449

A randomized study of rotigotine dose response on 'off' time in advanced Parkinson's disease.

Auteurs : Anthony. Nicholas [États-Unis] ; Rupam Borgohain [Inde] ; Pedro Chaná [Chili] ; Erwin Surmann [Allemagne] ; Emily. Thompson [Royaume-Uni] ; Lars Bauer [Allemagne] ; John Whitesides [États-Unis] ; Lawrence. Elmer [États-Unis]

Source :

RBID : pubmed:24643203

English descriptors

Abstract

Previous phase III studies in patients with advanced Parkinson's disease (PD) not adequately controlled on levodopa demonstrated significant reduction of 'off' time with rotigotine transdermal system up to 16 mg/24 h. However, the minimal effective dose has not been established.

DOI: 10.3233/JPD-130320
PubMed: 24643203

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pubmed:24643203

Le document en format XML

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<div type="abstract" xml:lang="en">Previous phase III studies in patients with advanced Parkinson's disease (PD) not adequately controlled on levodopa demonstrated significant reduction of 'off' time with rotigotine transdermal system up to 16 mg/24 h. However, the minimal effective dose has not been established.</div>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Previous phase III studies in patients with advanced Parkinson's disease (PD) not adequately controlled on levodopa demonstrated significant reduction of 'off' time with rotigotine transdermal system up to 16 mg/24 h. However, the minimal effective dose has not been established.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">This international, randomized, double-blind, placebo-controlled study (SP921; NCT00522379) investigated rotigotine dose response up to 8 mg/24 h.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients with advanced idiopathic PD (≥2.5 h of daily 'off' time on stable doses of levodopa) were randomized 1:1:1:1:1 to receive rotigotine 2, 4, 6, or 8 mg/24 h or placebo, titrated over 4 weeks and maintained for 12 weeks. The primary efficacy variable was change from baseline to end of maintenance in absolute time spent 'off'.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">409/514 (80%) randomized patients completed maintenance. Mean (±SD) baseline daily 'off' times (h/day) were placebo: 6.4 (±2.5), rotigotine 2-8 mg/24 h: 6.4 (±2.6). Rotigotine 8 mg/24 h was the minimal dose to significantly reduce 'off' time versus placebo. LS mean (±SE) absolute change in daily 'off' time (h/day) from baseline was -2.4 (±0.28) with rotigotine 8 mg/24 h, and -1.5 (±0.26) with placebo; absolute change in 'off' time in the 8 mg/24 h group compared with placebo was -0.85 h/day (95% CI -1.59, -0.11; p = 0.024). There was an apparent dose-dependent trend. Adverse events (AEs) reported at a higher incidence in the rotigotine 8 mg/24 h group versus placebo included application site reactions, nausea, dry mouth, and dyskinesia; there was no worsening of insomnia, somnolence, orthostatic hypotension, confusional state or hallucinations, even in patients ≥75 years of age.</AbstractText>
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