The phase 3 Boundless study (NCT04006210) has been initiated to investigate ND0612 (Mitsubishi Tanabe Pharma America, Jersey City, NJ) for Parkinson’s disease (PD). The ND0612 compound is a continuous subcutaneous formulation of carbidopa/levodopa (CD/LD) that is delivered without surgery.
The multicenter, randomized trial will enroll approximately 300 people with PD who have at least 2.5 hours of motor fluctuations daily, with a minimum of 2 hours every day in the "off" state during waking hours whose symptoms are no longer controlled by conventional treatments.
The primary objective of the study is to determine the effect of ND0612 on daily "good on" time (the sum of on time without dyskinesia and on time with nontroublesome dyskinesia), measured by a self-reported patient diary assessing motor function.
"While oral CD/LD is the established standard for treating motor symptoms in PD, many patients experience a decline in benefit as their disease advances, requiring them to take multiple doses throughout the day in an effort to control symptoms, often with unpredictable results," said Atsushi Fujimoto, president, Mitsubishi Tanabe Pharma America. "We look forward to researching the potential efficacy and safety of continuous subcutaneous treatment with ND0612 on managing motor fluctuations and other complications of PD through the Boundless study."
"Given the limitations of current therapeutic options for PD, we recognized the importance of developing a potential nonsurgical continuous treatment that may stabilize CD/LD plasma levels and alleviate the disabling motor fluctuations that are often exacerbated with disease progression," said Sheila Oren, MD, MBA, chief medical officer, NeuroDerm, Ltd. "We are excited that the Phase 3 study of ND0612 is underway, and we may be one step closer to potentially bringing a much-needed treatment option to patients."
Karissa Gable, MD
Thomas P. Leist, MD
Mark B. Skeen, MD