A controlled trial of lazabemide (Ro 19-6327) in levodopa-treated Parkinson's disease. Parkinson Study Group.

BACKGROUND

Lazabemide (Ro 19-6327) is a short-acting, reversible, highly selective inhibitor of monoamine oxidase type B, that, unlike selegiline (deprenyl), is not metabolized to active compounds.

DESIGN

A randomized, 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 levodopa.

METHODS

One hundred thirty-seven patients were enrolled at 14 centers and randomized to receive 100, 200, or 400 mg/d of lazabemide, or matching placebo. Subjects were followed up for 8 weeks, which included a randomized, double-blind withdrawal of lazabemide for either 2 or 4 weeks. The primary measure of tolerability was the proportion of treated subjects who were able to complete the study with their originally assigned treatment. Clinical features were assessed by the Unified Parkinson's Disease Rating Scale.

RESULTS

Lazabemide treatment was as well tolerated as placebo and was not attended by serious adverse experiences. There was a trend toward an increased frequency of adverse effects suggesting heightened dopaminergic activity among lazabemide-treated subjects. No significant improvement in the clinical features of Parkinson's disease was found after 4 weeks of lazabemide treatment.

CONCLUSIONS

The overall safety of lazabemide observed in this short-term study justifies further long-term investigations to determine if this monoamine oxidase type B inhibitor is a useful adjuvant to levodopa therapy in Parkinson's disease.