A randomized, fixed-dose, dose-response study of ropinirole prolonged release in advanced Parkinson's disease.
Neurodegener Dis Manag
; 7(1): 61-72, 2017 Feb.
Article
em En
| MEDLINE
| ID: mdl-28120630
ABSTRACT
AIM:
This Phase IV, double-blind, randomized, parallel-group study characterized the dose-response and tolerability of fixed doses of ropinirole prolonged release (PR) in subjects with advanced Parkinson's disease. PATIENTS &METHODS:
Subjects receiving concomitant l-dopa received once-daily ropinirole PR 4, 8, 12, 16 or 24 mg, or placebo, up-titrated for 13 weeks, maintained for 4 weeks.RESULTS:
At maintenance period week 4, ropinirole PR significantly reduced total awake 'Off-time' (16 mg; p = 0.027); increased absolute awake time spent 'On' without troublesome dyskinesia from baseline versus placebo (8 mg; p = 0.036); improved Unified Parkinson's Disease Rating Scale motor scores versus placebo (all doses; p = 0.005-0.016). Incidence of adverse events was similar between treatment groups; no dose-related trends were observed.CONCLUSION:
Ropinirole PR (16 mg) reduced 'Off-time' with 8 mg the likely lowest maximally effective dose, and the safety profile was consistent with previous studies.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Female
/
Humans
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Male
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article