Phase 3 of ND0612 clinical trial Initiated in the United States for Parkinson's disease with motor fluctuations
Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced the initiation of the Phase 3 BouNDless study investigating the efficacy, safety and tolerability of ND0612, a potential non-surgical, subcutaneous continuous treatment, compared to oral immediate-release carbidopa/levodopa (CD/LD) in people with Parkinson’s disease (PD) experiencing motor fluctuations.
“While oral CD/LD is the established standard for treating motor symptoms in Parkinson’s disease, 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, MTPA. “We look forward to researching the potential efficacy and safety of continuous subcutaneous treatment with ND0612 on managing motor fluctuations and other complications of Parkinson’s disease, through the BouNDless study.”
Motor fluctuations are alterations between periods of being "ON," during which a person with PD experiences a response to medication and symptoms are controlled, and being "OFF," which often is a debilitating reemergence of motor symptoms such as tremor, rigidity, slowness of movement, as well as impaired balance and falls. Instead of the relative control of symptoms people may experience with oral CD/LD treatment early on in their disease, symptoms return before the next dose is scheduled, or are only partially controlled by a given dose. 1,2 "Given the limitations of current therapeutic options for Parkinson’s disease, we recognized the importance of developing a potential non-surgical 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, M.D., 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.”
Clinical development of ND0612 is being led by NeuroDerm. If regulatory approval is obtained, MTPA intends to commercialize the therapy in the U.S. Both MTPA and NeuroDerm are wholly owned subsidiaries of Mitsubishi Tanabe Pharma Corporation (MTPC).The multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial will enroll a total of approximately 300 people with PD experiencing motor fluctuations, whose symptoms are no longer controlled by conventional treatments (average of at least 2.5 hours motor 2 fluctuations daily, with a minimum of 2 hours every day in the “OFF” state during waking hours), at approximately 120 sites globally. The primary objective of the study is to determine the effect of ND0612 on daily “GOOD ON” time (defined as the sum of “ON” time without dyskinesia and “ON” time with non-troublesome dyskinesia), as measured by a self-reported patient diary assessing motor function.