TOLCAPONE IMPROVES MOTOR FUNCTION AND REDUCES LEVODOPA REQUIREMENT INPATIENTS WITH PARKINSONS-DISEASE EXPERIENCING MOTOR FLUCTUATIONS - A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Tolcapone is a potent catechol-O-methyltransferase inhibitor that prol ongs the plasma half-life of levodopa. This multicenter, double-blind, placebo-controlled study used two 10-hour clinical evaluations to com pare the efficacy and safety of three doses of tolcapone (50, 200, and 400 mg tid) with placebo in patients with Parkinson's disease (PD) ex periencing motor fluctuations from levodopa/carbidopa. One hundred fif ty-one patients completed the study. Clinical evaluations lasting 10 h ours were performed on day -1 and day 42 using United Parkinson's Dise ase Rating Scale motor subscale and ''on/off'' and dyskinesia assessme nts every 30 minutes. Tolcapone significantly reduced ''off'' time an average of 40% and increased total ''on'' time by about 25% at all dos e levels, as compared to placebo treatment. Levodopa/carbidopa dosage and frequency were significantly reduced. Tolcapone was well tolerated , with patients experiencing typical dopaminergic side effects that co uld be reduced or eliminated by lowering levodopa/carbidopa dosages. T olcapone was effective at prolonging the clinical benefit of levodopa and reducing total levodopa requirements in PD patients with motor flu ctuations.