A prospective, randomized, placebo-controlled, double-blind, parallel-
group, 6-month study assessed the efficacy and safety of ropinirole, a
nonergoline D-2-dopamine agonist, in patients with early Parkinson's
disease (n = 241; Hoehn & Yahr stages I to III) with limited or no pri
or dopaminergic therapy. Patients (mean age, 62.8 years), stratified b
y concomitant use of selegiline, were randomized. to ropinirole (n = 1
16) or placebo (n = 125). The starting dose of ropinirole was 0.25 mg
tid with titration to at least 1.5 mg tid (maximum dose, 8 mg tid). Pr
imary efficacy endpoint was the percentage improvement in Unified Park
inson's Disease Rating Scale (UPDRS) motor score. Ropinirole-treated p
atients had a significantly greater percentage improvement in UPDRS mo
tor score than patients who received placebo (+24% vs -3%; p < 0.001).
Ropinirole was well tolerated and patient withdrawals were infrequent
. Most adverse experiences were related to peripheral dopaminergic act
ivity. Ropinirole monotherapy is an effective and well-tolerated thera
peutic option for treatment of early Parkinson's disease.