Subcutaneous infusion of ND0612 (a levodopa-carbidopa solution) increases on time without troublesome dyskinesia among patients with Parkinson disease, according to a study published in The Lancet Neurology. A research team examined the safety and efficacy of a continuous 24-hour/day subcutaneous infusion of ND0612 compared with oral immediate-release levodopa-carbidopa for the treatment of motor fluctuations in Parkinson disease. Participants underwent an open-label run-in phase and then randomly received (1:1) 12 weeks of treatment with their optimized regimen of subcutaneous ND0612 or oral levodopa-carbidopa, with matching oral or subcutaneous placebo given as required to maintain blinding. Researchers enrolled 381 participants and randomly assigned 259 to receive subcutaneous ND0612 (128; 49%) or oral levodopa-carbidopa (131; 51%). Researchers found that compared with oral levodopa-carbidopa, treatment with subcutaneous ND0612 provided an additional 1.72 hours of on time without troublesome dyskinesia (change from baseline, −0.48 and −2.20 hours, respectively). The study team observed significant treatment differences favoring subcutaneous ND0612 in the first four of nine prespecified hierarchical outcomes of daily off time (−1.40 hours), Movement Disorders Society-Unified Parkinson’s Disease Rating Scale part II scores (−3.05), Patients Global Impression of Change (OR, 5.31), and Clinical Global Impression of Improvement (OR, 7.23). After the fourth secondary endpoint, hierarchical testing ended.
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