New Randomized Trial Data on a Patch-Pump Approach for Treatment of Parkinson Disease

To further explore the safety and efficacy of a continuous subcutaneous levodopa–carbidopa infusion (ND0612) patch-pump for patients with Parkinson disease (PD) who manifest motor fluctuations, researchers conducted a manufacturer-funded, phase 3, randomized, double-blinded, double-dummy trial. There were 259 participants enrolled at 117 centers who completed an open-label run-in phase (12 weeks or less) to establish the optimal PD regimens for oral levodopa–carbidopa and for a continuous subcutaneous ND0612 infusion. Following randomization, each study arm received 12 weeks of double-blind treatment with the previously optimized regimen of either subcutaneous ND0612 (plus oral placebo) or oral levodopa–carbidopa (plus subcutaneous placebo)…