A placebo-controlled evaluation of ropinirole, a novel D2 agonist, as sole dopaminergic therapy in Parkinson's disease.

The efficacy and safety of ropinirole, a novel nonergot dopamine D2-like receptor agonist, was assessed as monotherapy for the treatment of patients with early-stage Parkinson's disease. In this double-blind, multicenter trial, patients were randomly allocated in a ratio of 2:1 to receive, over a 12-week period, either ropinirole or placebo. Clinical status was assessed using the Unified Parkinson's Disease Rating Scale (UP-DRS), Clinician's Global Evaluation (CGE), and a finger-tapping score. In all, 41 patients received ropinirole and 22 received placebo. The end-point analysis, on an intention-to-treat basis, revealed a significant difference (p = 0.018) in improvement in UP-DRS motor score from baseline between treatment groups (ropinirole, 43.4%; and placebo, 21.0%). Other parameters, including the number of responders and improvement in CGE, showed similar results. Three patients in the ropinirole group and one patient in the placebo group discontinued the study because of adverse events. There was no significant difference between the treatment groups in the overall incidence of adverse events. Although the dopaminergic side effects were reported significantly more frequently in the ropinirole group than in the placebo group (dizziness, p = 0.0326; nausea, p = 0.001; and somnolence, p = 0.005), none necessitated study withdrawal. There was no evidence of any chronic effect of the study medication on vital signs. In conclusion, ropinirole is a safe and well-tolerated drug and, as monotherapy, provided significant therapeutic benefit compared with placebo to patients in the early stages of Parkinson's disease.

RCT Entities:   Population Interventions Outcomes