A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients

第2相 完了 NCT01883505

概要

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.

Maximum Dermal Rating Score: Draize Score

14 days (Period 1) · score

Maximum Dermal Rating Score: Erythema and Eschar Formation

14 days (Period 1) · score

Maximum Dermal Rating Score: Edema

14 days (Period 1) · score

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