A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients
brief summary
This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.
detailed description
During Period 1, patients continued on their current standard of care (SoC) levodopa/carbidopa (LD/CD) and were randomized at 2:1 ratio to 14 days of adjunct treatment with ND0612 (daily LD/CD dose of 270/63 mg) or placebo infusion. During Period 2, patients were randomized to receive 7 days open-label treatment with ND0612 or ND0612 plus oral entacapone. Patients then entered a 4-week safety follow-up period.
official title
A Phase IIa Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open-label Period, to Evaluate the Safety, Tolerability, and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Subcutaneous ND0612