Alberto Espay, MD, MSc, University of Cincinnati, Cincinnati, OH, describes the results of a study that compared the efficacy and safety of continuous subcutaneous ND0612, an investigational, continuous 24-hours/day subcutaneous infusion of levodopa/carbidopa, with oral immediate-release levodopa/carbidopa (IR-LD/CD) in patients with Parkinson’s disease (PD) and motor fluctuations. The study was a double-blind, double-dummy (DBDD), parallel-group clinical trial (NCT04006210). Patients underwent 4-6 weeks of open-label IR-LD/CD dose adjustment and 4-6 weeks of open-label ND0612 conversion with adjunctive oral therapy as needed. Patients were then randomized to 12-week DBDD treatment with either their optimized ND0612 or IR-LD/CD regimens. Results from the DBDD trial showed a significant difference between the two arms. The ND0612 regimen provided an additional 1.72h of ON-time without troublesome dyskinesia compared to the optimized oral IR-LD/CD regimen. In addition, in an open-label study, patients on the ND0612 regimen gained almost 3h of ON-time. These results demonstrate clinically meaningful improvement in motor fluctuations, suggesting this treatment strategy could benefit patients with motor fluctuations who are considered for advanced therapies. This interview took place at the AAN Annual Meeting 2023 in Boston, MA.
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Dr. Espay has received grant support from the NIH and the Michael J Fox Foundation; personal compensation as a consultant/scientific advisory board member for Neuroderm, Amneal, Acadia, Avion Pharmaceuticals, Acorda, Kyowa Kirin, Sunovion, Supernus (formerly, USWorldMeds), and Herantis Pharma; personal honoraria for speakership for Avion, Amneal, and Supernus; and publishing royalties from Lippincott Williams & Wilkins, Cambridge University Press, and Springer. He cofounded REGAIN Therapeutics and is co-inventor of the patent “Compositions and methods for treatment and/or prophylaxis of proteinopathies.” He serves on the editorial boards of the Journal of Parkinson’s Disease, Journal of Alzheimer’s Disease, European Journal of Neurology, Movement Disorders Clinical Practice, and JAMA Neurology.