Date: 2016-05-09
Type of
information: Initiation of the trial
phase:
Announcement: initiation of patient enrollment
Company: Neuroderm (Israel)
Product: ND0612
Action
mechanism:
Disease: Parkinson's disease
Therapeutic
area: Neurodegenerative diseases
Country:
Trial
details:
Latest
news:
- • On May 9, 2016, NeuroDerm announced the start of patient enrollment in a long-term safety study (trial 012) of the company’s continuously administered subcutaneous levodopa/carbidopa (LD/CD) formulation used in both ND0612H and ND0612L.
- The one-year international, open label study will investigate the long-term safety of low and high dose regimens of ND0612. The study is expected to enroll approximately 100 patients, including patients who have previously completed the company’s phase 2 and 3 studies as well as new patients. At least 50 patients will be treated with the highest dose regimen. ND0612, continuously administered through a belt pump, is designed to maintain steady LD/CD levels to improve motor fluctuations that cannot be adequately controlled with oral therapy and, in the case of advanced patients, provide an alternative to treatments requiring surgical intervention.
- Upon the completion of this trial anticipated in 2017, as well as the other parallel trials outlined in our clinical development plan, Neuroderm intends to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
Is
general: Yes
