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
Public ClinicalTrials.gov record NCT04006210. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel-group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)
Study identification
- NCT ID
- NCT04006210
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- NeuroDerm Ltd.
- Industry
- Enrollment
- 381 participants
Conditions and interventions
Conditions
Interventions
- ND0612 Solution for SC infusion Combination Product
- Oral IR-LD/CD Drug
- Placebo for Oral IR-LD/CD Drug
- Placebo for SC infusion Combination Product
Combination Product · Drug
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 29, 2019
- Primary completion
- Oct 31, 2022
- Completion
- Jan 31, 2027
- Last update posted
- May 20, 2025
2019 – 2027
United States locations
- U.S. sites
- 38
- U.S. states
- 25
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Xenoscience | Phoenix | Arizona | 85004 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Cedar- Sinai Medical Center Department of Neurology | Los Angeles | California | 90048 -1804 | — |
| SC3 Research - Reseda | Reseda | California | 91335 | — |
| University of California San Francisco | San Francisco | California | 94115 | — |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | — |
| Hartford Healthcare Chase Family Movement Disorders Center | Vernon | Connecticut | 06066 | — |
| Visionary Investigators Network | Aventura | Florida | 33180 | — |
| Parkinsons Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486-2359 | — |
| University of Florida Norman Fixel Institute for Neurological Diseases | Gainesville | Florida | 32608 | — |
| Neurology Associates PA | Maitland | Florida | 32751-4723 | — |
| USF Parkinson's Disease and Movement Disorders Center | Tampa | Florida | 33613 | — |
| Neurology One | Winter Park | Florida | 32792 | — |
| Emory University - Brain Health Center | Atlanta | Georgia | 30329 | — |
| NeuroStudies | Decatur | Georgia | 30033 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Unity Point Health | Des Moines | Iowa | 50309 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky, Neurology and Movement Disorder | Lexington | Kentucky | 40536-0284 | — |
| Oschner Medical Center | New Orleans | Louisiana | 70121 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Michigan State University | East Lansing | Michigan | 48824 | — |
| QUEST Research Institute | Farmington Hills | Michigan | 48334-2980 | — |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | — |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Weill Cornell Medicine | New York | New York | 10021 | — |
| Mount Sinai Medical center Movement Disorders Center | New York | New York | 10029 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Corporal Michael J. Crescenz VA Medical Center | Philadelphia | Pennsylvania | 19101-4511 | — |
| Abington Neurological Associates LTD. | Willow Grove | Pennsylvania | 19090-1749 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Neurology Consultants of Dallas | Dallas | Texas | 75243 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Virginia | Charlottesville | Virginia | 22908-0816 | — |
| University of Wisconsin Madison | Madison | Wisconsin | 53705-2281 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04006210, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2025 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04006210 live on ClinicalTrials.gov.