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 UK 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

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)

Facility	City	Region
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.

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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 the UK