An acute and long-term study with a dispersible formulation of levodopa/benserazide (Madopar®) in Parkinson's disease

The clinical efficacy, tolerability and administration regimens of a dispersible formulation of levodopa/benserazide (DM) were investigated in 30 patients with idiopathic Parkinson's disease, complicated by motor fluctuations. All 30 patients showed delayed-'on' phenomenon after administration of the first morning dose of standard levodopa (SM), and 20 showed delayed-'on' phenomenon after the first afternoon dose. Patients were receiving standard formulations of levodopa as monotherapy or in combination. A double-dose study of the dispersible vs the standard formulation was performed in 30 patients, 24 of whom participated in a 36-month, follow-up clinical study. In the long-term study, SM was replaced with DM by substituting the first morning dose or the first morning and first afternoon doses. In the double-dose study, mean latency to 'on' after the first morning dose was significantly shorter with DM than with SM (p <0.001), whereas the duration of 'on' was similar with the two preparations. The post-prandial delayed-'on' in the 14 patients who responded to therapy was significantly shorter for DM than for SM (p <0.001). In the long-term study, the mean latency to 'on' in all patients was significantly shorter than at baseline (p <0.001). Time spent in 'on' during the active day increased significantly, and remained stable during the 36-month study. No changes were apparent in the mean dosage of levodopa/day or the number of doses/day, and no acute or long-term adverse events were reported. In conclusion, these results confirm the long-term safety of the dispersible formulation, and its improved efficacy compared with standard levodopa formulations, as monotherapy and in association with slow-release formulations.