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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- COMBINATION_PRODUCT ND0612 Solution for SC infusion
- COMBINATION_PRODUCT Placebo for SC infusion
- DRUG Oral IR-LD/CD
- DRUG Placebo for Oral IR-LD/CD
Study Locations (20)
Florida
- Visionary Investigators Network — Aventura
- Parkinsons Disease and Movement Disorders Center of Boca Raton — Boca Raton
- University of Florida Norman Fixel Institute for Neurological Diseases — Gainesville
- Neurology Associates PA — Maitland
- USF Parkinson's Disease and Movement Disorders Center — Tampa
- Neurology One — Winter Park
California
- Cedar- Sinai Medical Center Department of Neurology — Los Angeles
- SC3 Research - Reseda — Reseda
- University of California San Francisco — San Francisco
Georgia
- Emory University - Brain Health Center — Atlanta
- NeuroStudies — Decatur
Arizona
- Xenoscience — Phoenix
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Colorado
- Rocky Mountain Movement Disorders Center — Englewood
Connecticut
- Hartford Healthcare Chase Family Movement Disorders Center — Vernon
Hawaii
- Hawaii Pacific Neuroscience — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2027-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04006210
The ClinicalTrials.gov registry entry for NCT04006210 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 381 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeuroDerm, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 4 interventions — of which ND0612 Solution for SC infusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04006210 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04006210 about?
NCT04006210 is a clinical study titled "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". 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 w...
What is the current status of trial NCT04006210?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2019-09-30. Estimated completion is 2027-02.
What conditions does trial NCT04006210 study?
This clinical trial studies the following conditions: Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04006210?
The interventions under investigation include: ND0612 Solution for SC infusion (COMBINATION_PRODUCT), Placebo for SC infusion (COMBINATION_PRODUCT), Oral IR-LD/CD (DRUG), Placebo for Oral IR-LD/CD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04006210?
This trial is sponsored by NeuroDerm, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04006210 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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