Ropinirole for the treatment of early Parkinson's disease. The Ropinirole Study Group.

Author(s): Adler CH, Sethi KD, Hauser RA, Davis TL, Hammerstad JP, Bertoni J, Taylor RL, Sanchez-Ramos J, O'Brien CF

Affiliation(s): Department of Neurology of the Mayo Clinic, Scottsdale, AZ 85259, USA.

Publication date & source: 1997-08, Neurology., 49(2):393-9.

Publication type: Clinical Trial; Randomized Controlled Trial

A prospective, randomized, placebo-controlled, double-blind, parallel-group, 6-month study assessed the efficacy and safety of ropinirole, a nonergoline D2-dopamine agonist, in patients with early Parkinson's disease (n = 241; Hoehn & Yahr stages I to III) with limited or no prior dopaminergic therapy. Patients (mean age, 62.8 years), stratified by concomitant use of selegiline, were randomized to ropinirole (n = 116) 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). Primary efficacy endpoint was the percentage improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score. Ropinirole-treated patients had a significantly greater percentage improvement in UPDRS motor 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 activity. Ropinirole monotherapy is an effective and well-tolerated therapeutic option for treatment of early Parkinson's disease.