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Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

NCT04006210 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2025-05-21

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD.

Subjects can continue to an optional open-label extension period.

Conditions

Interventions

COMBINATION_PRODUCT

ND0612 Solution for SC infusion

Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump

COMBINATION_PRODUCT

Placebo for SC infusion

Placebo solution administered SC via infusion pump

DRUG

Oral IR-LD/CD

Encapsulated LD/CD 100mg/25mg

DRUG

Placebo for Oral IR-LD/CD

Encapsulated Placebo for LD/CD 100mg/25mg

Sponsors & Collaborators

  • NeuroDerm Ltd.

    lead INDUSTRY

Principal Investigators

  • Alberto J Espay, MD, MSc · University of Cincinnati OH, USA

  • Olivier Rascol, MD, PhD · Toulouse University Hospital, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2022-11-01
Completion
2027-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT04006210 on ClinicalTrials.gov