drugset / Trial / NCT01883505

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

NCT01883505

Phase 2 Completed 30 enrolled NeuroDerm Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-01-06
Primary completion
2015-04-26
Completion
2015-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Entacapone Small molecule 200 mg Oral
Subject ND0612 Unknown Subcutaneous

Indications