Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.
Mov Disord
; 28(10): 1447-50, 2013 Sep.
Article
em En
| MEDLINE
| ID: mdl-23801585
ABSTRACT
BACKGROUND:
We conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan.METHODS:
Patients received once-daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment.RESULTS:
The mean (± standard deviation) changes in UPDRS part II and III scores were -8.4 ± 9.7 in the rotigotine group and -4.1 ± 8.2 in the placebo group and were significantly different (P = 0.002). More patients in the rotigotine group than in the placebo group had a ≥ 20% score reduction. No serious drug-related adverse events were reported.CONCLUSIONS:
Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Doença de Parkinson
/
Tetra-Hidronaftalenos
/
Tiofenos
/
Antiparkinsonianos
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Mov Disord
Assunto da revista:
NEUROLOGIA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Japão