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: Review the eligibility criteria below.
Location: Xenoscience — Phoenix, Arizona
Age range: 30 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
- Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease — New Haven, Connecticut
- Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD — Phoenix, Arizona
- Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS — Lexington, Kentucky
- ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease — Toronto, Ontario
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.