Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT04006210
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science France tracker
Sponsor
NeuroDerm Ltd
Phase
Phase 3
Started
2019-09-30
Last updated
2025-05-21

Condition(s) studied

Parkinson's Disease

Investigational drug(s) / intervention(s)

ND0612 Solution for SC infusionPlacebo for SC infusionOral IR-LD/CDPlacebo for Oral IR-LD/CD

ND0612 Solution for SC infusion: Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump

Placebo for SC infusion: Placebo solution administered SC via infusion pump

Oral IR-LD/CD: Encapsulated LD/CD 100mg/25mg

Placebo for Oral IR-LD/CD: Encapsulated Placebo for LD/CD 100mg/25mg

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male and female patients, aged ≥30 years. 2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria. 3. Modified Hoehn \& Yahr score ≤3 during "ON" state. 4. Average of ≥2.5 hours of OFF time (≥2 hours "OFF" time every day) during waking hours as confirmed by patient diary over 3 days. 5. Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of ≥400mg. Exclusion Criteria: 1. Atypical or secondary parkinsonism. 2. Severe disabling dyskinesias, based on Investigator's discretion. 3. Previous neurosurgery for PD. 4. Use of duodenal levodopa infusion (LCIG) or apomorphine infusion. 5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks. 6. Previous participation in ND0612 studies. 7. History of significant skin conditions or disorders.

Primary outcome measure(s)

  • The change in daily ON time without troublesome dyskinesia — Baseline to the end of DBDD Maintenance Period (12 weeks)
    ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary

Trial sites (103)

FacilityCityRegionStatus
Xenoscience Phoenix Arizona
University of Arkansas for Medical Sciences Little Rock Arkansas
Cedar- Sinai Medical Center Department of Neurology Los Angeles California
SC3 Research - Reseda Reseda California
University of California San Francisco San Francisco California
Rocky Mountain Movement Disorders Center Englewood Colorado
Hartford Healthcare Chase Family Movement Disorders Center Vernon Connecticut
Visionary Investigators Network Aventura Florida
Parkinsons Disease and Movement Disorders Center of Boca Raton Boca Raton Florida
University of Florida Norman Fixel Institute for Neurological Diseases Gainesville Florida
Neurology Associates PA Maitland Florida
USF Parkinson's Disease and Movement Disorders Center Tampa Florida
Neurology One Winter Park Florida
Emory University - Brain Health Center Atlanta Georgia
NeuroStudies Decatur Georgia
Hawaii Pacific Neuroscience Honolulu Hawaii
Rush University Medical Center Chicago Illinois
Unity Point Health Des Moines Iowa
University of Kansas Medical Center Kansas City Kansas
University of Kentucky, Neurology and Movement Disorder Lexington Kentucky
Oschner Medical Center New Orleans Louisiana
Beth Israel Deaconess Medical Center Boston Massachusetts
Michigan State University East Lansing Michigan
QUEST Research Institute Farmington Hills Michigan
Henry Ford West Bloomfield Hospital West Bloomfield Michigan
Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey
Weill Cornell Medicine New York New York
Mount Sinai Medical center Movement Disorders Center New York New York
Duke University Durham North Carolina
University of Cincinnati Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
Corporal Michael J. Crescenz VA Medical Center Philadelphia Pennsylvania
Abington Neurological Associates LTD. Willow Grove Pennsylvania
Medical University of South Carolina Charleston South Carolina
Neurology Consultants of Dallas Dallas Texas
University of Vermont Medical Center Burlington Vermont
University of Virginia Charlottesville Virginia
University of Wisconsin Madison Madison Wisconsin
Medical University Innsbruck Innsbruck Austria
CHU de Tivoli La Louvière Belgium

+ 63 more sites — see the full list on the official registry below.

More NeuroDerm Ltd. trials in France

A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease Active, not recruiting

Other trials for the same condition

Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care Recruiting
Prevent Cognitive Decline in GBA-associated Parkinson's Disease Recruiting
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease Recruiting
Combined Genome and RNA Sequencing for Genetic Diagnosis of Parkinsonism Recruiting
Subthalamic Nucleus, Akinesia and Parkinson's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04006210 on ClinicalTrials.gov ↗ ← All trials in France