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A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients

Parkinson's Disease Clinical Trial

Official title:
A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients

Clinical Trial Summary

In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

Clinical Trial Description

Design: single center, double-blind, randomized, placebo-controlled, crossover study. Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments. Population: Eight (8) PD subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01725802
Study type Interventional
Source NeuroDerm Ltd.
Contact
Status Completed
Phase Phase 1
Start date December 16, 2012
Completion date February 26, 2013
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