A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease.
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 </= 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90% CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.
Singer
Carlos
C
Department of Neurology, University of Miami, Miami, Florida, USA. csinger@med.miami.edu
Lamb
Janice
J
Ellis
Amanda
A
Layton
Gary
G
D000328:Adult; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D003710:Demography; D018491:Dopamine Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010300:Parkinson Disease / Q000175:diagnosis* / Q000188:drug therapy*
D001562:Benzimidazoles; D018491:Dopamine Agonists; D007211:Indoles; C046649:ropinirole; C108539:U 95666E