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|NeuroDerm Presents ND0612H Phase II Trial Results in Late-Breaking Poster Session at the 21st International Congress of Parkinson’s Disease and Movement Disorders|
-ND0612H achieved a complete reduction of OFF-time to zero in 42% of patients treated for 24 hours -
- Statistically significant and clinically meaningful reduction in OFF-time and increase in the portion of patients "ON" by
Trial 006 was an international open label, blinded rater, phase II study of ND0612H, NeuroDerm's high dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation, in patients with advanced Parkinson's disease. In March 2017, NeuroDerm announced that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints, with many patients experiencing a complete reduction of OFF-time to zero.
“The significant increase in Good ON time coupled with a significant reduction in OFF time, including a complete resolution of OFF time to zero in 42% of patients in the first of our two regimens, demonstrates the substantial potential of 24-hour administration of ND0612H,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “The results of this study offer additional evidence that this innovative therapy can transform the care and outcome for patients with advanced Parkinson’s disease, and suggest that ND0612 can provide significant patient benefit without the surgical risks associated with deep brain stimulation and LD/CD intestinal gel.”
Trial 006 Design
All patients could add oral LD/CD therapy at any time as needed. The trial enrolled 38 patients with advanced Parkinson’s disease.
Tamar Rachmilewitz MD, Medical Director at NeuroDerm will present additional baseline patient characteristic data from trial 006 in an abstract titled, “Baseline characteristics of the population enrolled to a randomized clinical study of subcutaneous levodopa/carbidopa (ND0612) infusion in patients with advanced PD,” (Abstract 1377) in a poster session on Thursday, June 8, from 1:
Trial 006 Endpoints
Trial 006 Study Efficacy and Safety Results
Primary endpoint (OFF-time) and key secondary endpoint (“ON” by
In R1, the proportion of patients who achieved the first “ON” by 8:00am (as reported by the patient) increased from 11% at baseline to 50% by day 28 (p = 0.02), and, by 9:00am, from 32% at baseline to 75% (p = 0.007).
Good ON (secondary endpoint):
Complete reduction of OFF-time (post-hoc analysis):
Troublesome Dyskinesia (post hoc analysis):
Reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) III (post-hoc analysis):
Safety and Tolerability:
Additionally, the ND0612H infusion pump systems were reliable with only few minor, correctable malfunctions reported. No major inconvenience related to the wearing of the device was reported for either day or night administration.
The following abstracts featuring
U.S. Investor Contact: