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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT04006210

Run by

NeuroDerm Ltd.

People needed

381

Starts

2019-09-30

Expected to finish

2027-02-01

Last updated by the study team

2025-05-21

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients, aged ≥30 years.
• PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
• Modified Hoehn \& Yahr score ≤3 during "ON" state.
• 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.
• 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.

You may not qualify if…

• Atypical or secondary parkinsonism.
• Severe disabling dyskinesias, based on Investigator's discretion.
• Previous neurosurgery for PD.
• Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
• Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
• Previous participation in ND0612 studies.
• History of significant skin conditions or disorders.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Cedar- Sinai Medical Center Department of Neurology — Los Angeles, California, United States
• SC3 Research - Reseda — Reseda, California, United States
• University of California San Francisco — San Francisco, California, United States
• Rocky Mountain Movement Disorders Center — Englewood, Colorado, United States
• Hartford Healthcare Chase Family Movement Disorders Center — Vernon, Connecticut, United States
• Visionary Investigators Network — Aventura, Florida, United States
• Parkinsons Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• University of Florida Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States
• Neurology Associates PA — Maitland, Florida, United States
• USF Parkinson's Disease and Movement Disorders Center — Tampa, Florida, United States
• Neurology One — Winter Park, Florida, United States
• Emory University - Brain Health Center — Atlanta, Georgia, United States
• NeuroStudies — Decatur, Georgia, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Unity Point Health — Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky, Neurology and Movement Disorder — Lexington, Kentucky, United States
• Oschner Medical Center — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Michigan State University — East Lansing, Michigan, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States
• Xenoscience — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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