title: A randomized, fixed-dose, dose-response study of ropinirole prolonged release in advanced Parkinson's disease.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of South Florida, Tampa, FL, USA.
authors.forename: Theresa A
authors.initials: TA
authors.lastname: Zesiewicz
authors.affiliation: GlaxoSmithKline, Research Triangle Park, Raleigh-Durham, NC, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Chriscoe
authors.affiliation: GlaxoSmithKline, Research Triangle Park, Raleigh-Durham, NC, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Jimenez
authors.affiliation: GlaxoSmithKline, Stevenage, Hertfordshire, UK.
authors.forename: James
authors.initials: J
authors.lastname: Upward
authors.affiliation: GlaxoSmithKline, Stevenage, Hertfordshire, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Davy
authors.affiliation: GlaxoSmithKline, Research Triangle Park, Raleigh-Durham, NC, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: VanMeter
mesh_terms: D000328:Adult; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D007980:Levodopa / Q000008:administration & dosage; D060046:Maintenance Chemotherapy; D008297:Male; D010300:Parkinson Disease / Q000188:drug therapy*
chemical_list: D000978:Antiparkinson Agents; D007211:Indoles; C046649:ropinirole; D007980:Levodopa
keywords: advanced Parkinson's disease; dose–response; ropinirole; ropinirole prolonged release; total awake time ‘Off’