Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT01883505
PHASE2

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

Sponsor: NeuroDerm Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2014-01-06

Completion Date

2015-04-26

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

ND0612

Subcutaneous infusion via CRONO ND pump

DRUG

Placebo

Subcutaneous infusion via CRONO ND pump

DRUG

Entacapone

200 mg oral tablet

Locations (3)

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Tel Aviv Medical Center

Tel Aviv, Israel