Randomized, placebo-controlled study of tolcapone in patients with fluctuating Parkinson disease treated with levodopa-carbidopa

Abstract

Objective: To assess the efficacy and tolerability of the catechol-O- methyltransferase inhibitor tolcapone in reducing 'off/on' fluctuations in levodopa-treated parkinsonian patients. Design: A randomized, double-blind, placebo-controlled, parallel-group study. Setting: Fifteen Parkinson disease clinics. Patients: Two hundred fifteen referred outpatients with Parkinson disease who showed predictable end-of-dose motor fluctuations that were not controlled by a stable levodopa-carbidopa (Sinemet) regimen of at least 4 weeks' duration. Interventions: In addition to their usual levodopa- carbidopa regimen, patients received placebo or tolcapone, 100 or 200 mg, 3 times daily orally for 6 weeks. Primary Outcome Measure: Change in daily off/on time. Results: Tolcapone, 100 and 200 mg 3 times daily, reduced off time by 2.0 and 2.5 hours per day, respectively, and increased on time by 2.1 and 2.3 hours per day, respectively (P