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A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612

NCT01883505 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-18

No results posted yet for this study

Summary

This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Conditions

Interventions

DRUG

Levodopa and carbidopa

Subcutaneous continuous administration

DRUG

Placebo

Subcutaneous continuous administration

Sponsors & Collaborators

  • NeuroDerm Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01883505 on ClinicalTrials.gov