The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost-writing (Movement Disorders Vol 20, No. 12, 2005, p. 1536). The first-named author has taken full responsibility for the data and the accuracy of the analysis. All authors had full access to the data.
A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease†
Article first published online: 22 FEB 2007
Copyright © 2007 Movement Disorder Society
Volume 22, Issue 4, pages 476–482, 15 March 2007
How to Cite
Singer, C., Lamb, J., Ellis, A. and Layton, G. (2007), A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease. Mov. Disord., 22: 476–482. doi: 10.1002/mds.21361
Members of the Sumanirole for Early Parkinson's Disease Study Group are listed as an Appendix
- Issue published online: 27 MAR 2007
- Article first published online: 22 FEB 2007
- Manuscript Accepted: 9 NOV 2006
- Manuscript Received: 14 SEP 2006
- Pfizer Inc.
- Parkinson's disease;
- dopamine agonist;
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 to16 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. © 2007 Movement Disorder Society