NCT01725802

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa/carbidopa solution for SC administration
DRUG	Placebo

Timeline

• Start date: 2012-12-16
• Primary completion: 2013-02-26
• Completion: 2013-02-26
• First posted: 2012-11-14
• Last updated: 2024-05-01

Locations

1 site across 1 country: Israel