Date: 2016-12-22
Type of
information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Neuroderm (Israel)
Product: ND0612H (levodopa and carbidopa administered through a pump patch)
Action
mechanism: ND0612 is designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of levodopa/carvidopa solution. A high dose of ND0612 (ND0612H), intended for severe Parkinson's disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.
Disease: Parkinson's disease
Therapeutic
area: Neurodegenerative diseases
Country:
Trial
details: Trial 006 is a 28-day multicenter, parallel-group, rater-blinded, randomized pilot phase II study that will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of two dosing regimens of ND0612H and compare them to the baseline oral standard of care. The study is expected to enroll a total of 36 advanced Parkinson’s disease patients at sites in Israel, Europe and the United States. Patient enrollment has been ongoing since December 2015. The study is expected to be completed in the second half of 2016.
Latest
news:
- • On December 22, 2016, NeuroDerm announced that it completed patient enrollment and treatment in trial 006 of ND0612H, the company's continuously administered levodopa/carbidopa (LD/CD) solution. ND0612H, administered subcutaneously through a belt pump, is designed to deliver steady LD/CD levels to advanced Parkinson's patients with motor fluctuations that cannot be adequately controlled with oral therapy and to become an alternative to treatments with surgical intervention.
- The study enrolled a total of 38 patients with advanced Parkinson's disease. Topline results from this trial are expected in the first quarter of 2017.
- • On June 30, 2016, NeuroDerm announced the start of patient enrollment in the United States in an ongoing phase II efficacy trial (Trial 006) of ND0612H, the company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation. Trial 006, which was initiated in December 2015, is a multicenter international phase II clinical study designed to compare the efficacy, safety and tolerability of ND0612H to the baseline oral standard of care. ND0612H, administered through a belt pump, is designed to deliver steady LD/CD levels and improve motor fluctuations that cannot be adequately controlled with oral therapy and might otherwise require surgical intervention. Trial 006 is expected to enroll a total of 36 advanced Parkinson’s disease patients at sites in Israel, Europe and the United States. Patient enrollment has been ongoing since December 2015. The study is expected to be completed in the second half of 2016.
Is
general: Yes
