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A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations

NCT02782481 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-12-10

No results posted yet for this study

Summary

This is a multicenter, randomized, double blind, placebo controlled parallel group clinical study. Following a screening period of up to 28 days, eligible subjects will be randomized to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous subcutaneous infusion of ND0612 or matching placebo for 16 weeks.

Conditions

Interventions

DRUG

ND0612

DRUG

Placebo

Sponsors & Collaborators

  • NeuroDerm Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-10-15
Completion
2018-10-15

Countries

  • Israel

Study Locations

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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 NCT02782481 on ClinicalTrials.gov