Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease (NCT06107426)
A Global Real-World Evidence Study on the Long-term Effectiveness of ABBV-951 in Advanced Parkinson´s Disease in Routine Clinical Practice (ROSSINI: Real-world Outcomes With continuouS Subcutaneous Levodopa INfusIon)
🩺 Plain-English Summary (8th-Grade Level)
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting. ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain. All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years. Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham - Main /ID# 253477 — Birmingham, Alabama
Age range: 18 Years
📋 "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 (68 Sites)
Showing the first 25 of 68 sites.
- University of Alabama at Birmingham - Main /ID# 253477 — Birmingham, Alabama
- Banner Sun Health Research Institute /ID# 253461 — Sun City, Arizona
- Parkinson's Research Centers of America - Palo Alto /ID# 264703 — Palo Alto, California
- Georgetown University Hospital /ID# 259381 — Washington D.C., District of Columbia
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465 — Boca Raton, Florida
- University of Florida College of Medicine /ID# 259383 — Gainesville, Florida
- University of Miami /ID# 259396 — Miami, Florida
- N1 Research, LLC /ID# 264221 — Orlando, Florida
- University of South Florida- Neuroscience Institute /ID# 253470 — Tampa, Florida
- Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977 — Chicago, Illinois
- Ochsner Medical Center - Jefferson Highway /ID# 269764 — New Orleans, Louisiana
- Boston Medical Center Health System /ID# 269765 — Brighton, Massachusetts
- University of Minnesota - Minneapolis /ID# 268121 — Minneapolis, Minnesota
- Kansas City VA Medical Center /ID# 253466 — Kansas City, Missouri
- Cleveland Clinic Lou Ruvo Cent /ID# 259390 — Las Vegas, Nevada
- David L. Kreitzman, MD, PC /ID# 259397 — Commack, New York
- Northwell Health /ID# 253469 — Lake Success, New York
- Novant Health Neurology and Sleep /ID# 259391 — Charlotte, North Carolina
- Atrium Health Wake Forest Baptist Medical Center /ID# 259387 — Winston-Salem, North Carolina
- NeuroCare Center /ID# 259392 — Canton, Ohio
- The Movement Disorder Clinic of Oklahoma /ID# 253463 — Tulsa, Oklahoma
- Vanderbilt University Medical Center /ID# 253474 — Nashville, Tennessee
- Texas Movement Disorder Specialists /ID# 253473 — Georgetown, Texas
- Univ Texas HSC San Antonio /ID# 259394 — San Antonio, Texas
- University of Utah /ID# 253471 — Salt Lake City, Utah
💰 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 (PD)
- A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease — Aliso Viejo, California
- IMPACT 360 for Parkinson's Disease — Vancouver, British Columbia
- AAV2-hAADC for Parkinson's Disease (PDCS-01) — Columbus, Ohio
- Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease — Stanford, California
- A Study of Buntanetap in Participants With PD — Birmingham, Alabama
Explore by condition: All Parkinson's Disease (PD) 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.