In a phase 2 trial (NCT02577523), participants with advanced Parkinson’s disease (PD) treated with continuous subcutaneous delivery of carbidopa/levodopa (ND0612); NeuroDerm, Jersey City, NJ) had statistically significant improvements in quality of life. Participants treated with continuous 24-hour ND0612 had a 2.9-point improvement on the Unified Parkinson’s Disease Rating Scale Part II (UPDRS ADL) from baseline (P = .02) and a 7.5-point improvement on the Parkinson’s Disease Questionnaire (PDQ-39) compared with their baseline (P = .02).
Improvement was seen in 6 of 8 PDQ-39 quality of life domains, including bodily discomfort, activities of daily living, emotional well-being, mobility, communication, and stigma. More than 70% of patients reported an improvement in overall clinical status as early as day 3.
“We are encouraged by the patient-reported outcomes with ND0612, which show the potential impact of stabilizing CD/LD levels with continuous treatment on a variety of clinical, daily living, and quality of life measures,” said Sheila Oren, MD, MBA, chief medical officer, NeuroDerm. “We are proud of the research behind ND0612 to date and committed to learning more about this investigational treatment for people with fluctuating PD through the recently initiated Phase 3 study.”
In this randomized parallel-group study, 38 participants were randomly assigned to be treated with ND0612 continuously subcutaneously for 14 or 24 hours. Supplemental oral CD/LD was used as needed. Patient-reported outcomes were measured using the UPDRS ADL at day 28 and the PDQ-39) at day 27. Patients self-rated their impressions of improvement at days 3 and 28.
Paul M. Elsbernd, MD; Kathryn J. Lago, DO; Tatjana P. Calvano, DO; and John H. Sladky, MD
Elizabeth Ackley, MD, and Marcy E. Yonker, MD, FAHS
James Geyer, MD, and Paul Cox