A CONTROLLED TRIAL OF LAZABEMIDE (RO-19-6327) IN LEVODOPA-TREATED PARKINSONS-DISEASE

Background: Lazabemide (Ro 19-6327) is a short-acting, reversible, hig hly selective inhibitor of monoamine oxidase type B, that, unlike sele giline (deprenyl), is not metabolized to active compounds. Design: A r andomized, double-blind clinical trial to assess the short-term safety and tolerability and the effect on motor performance of lazabemide in subjects who had Parkinson's disease requiring treatment with levodop a. Methods: One hundred thirty-seven patients were enrolled at 14 cent ers and randomized to receive 100, 200, or 400 mg/d of lazabemide, or matching placebo. Subjects were followed up for 8 weeks, which include d a randomized, double-blind withdrawal of lazabemide for either 2 or 4 weeks. The primary measure of tolerability was the proportion of tre ated subjects who were able to complete the study with their originall y assigned treatment. Clinical features were assessed by the Unified P arkinson's Disease Rating Scale. Results: Lazabemide treatment was as well tolerated as placebo and was not attended by serious adverse expe riences. There was a trend toward an increased frequency of adverse ef fects suggesting heightened dopaminergic activity among lazabemide-tre ated subjects. No significant improvement in the clinical features of Parkinson's disease was found after 4 weeks of lazabemide treatment. C onclusions: The overall safety of lazabemide observed in this short-te rm study justifies further longterm investigations to determine if thi s monoamine oxidase type B inhibitor is a useful adjuvant to levodopa therapy in Parkinson's disease.