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)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: Xenoscience — Phoenix, Arizona
Age range: 30 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (103 Sites)
Showing the first 25 of 103 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Parkinson's Disease
- Genotypic Influences on Network Progression in Parkinson's Disease — Manhasset, New York
- Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics — Boston, Massachusetts
- Non-invasive VNS for Parkinson's Gait — Hines, Illinois
- Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease — New Haven, Connecticut
- Modifiable Variables in Parkinsonism (MVP) — Kenmore, Washington
Explore by condition: All Parkinson's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.