Reduce off time and fluctuations
- Trial ID
- NCT06107426
- Official Title
- 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)
- Goal
- Reduce off time and fluctuations
- Status
- RECRUITING
- Sponsor
- AbbVie
- Study Type
- OBSERVATIONAL
- Enrollment
- 450 participants
- Conditions
- Parkinson's Disease (PD)
Plain-Language Summary
The goal is to see whether ABBV-951, a continuous subcutaneous levodopa infusion, provides durable real-world control of motor symptoms and reduces off time and fluctuations in people with advanced, levodopa-responsive Parkinson's. ABBV-951 delivers levodopa continuously under the skin via an infusion pump to keep steadier blood levels than intermittent oral doses, which may smooth out on/off swings and could reduce peak-dose dyskinesia; because it is levodopa, it directly replaces or supplements oral levodopa rather than working on a different pathway. The study is looking for adults 18 and older with idiopathic, levodopa-responsive PD who are either starting ABBV-951 per local label or who previously completed specific ABBV-951 extension studies, and participants must meet local label rules, have acceptable cognitive status (MMSE 24+ or 19,23 with a permanent caregiver), with exclusions for label contraindications, significant skin issues, or enrollment in other interventional trials. About 450 people worldwide will be followed in routine clinical practice to collect long-term real-world outcomes.
Locations
- University of Alabama at Birmingham - Main /ID# 253477, Birmingham, Alabama, United States
- Banner Sun Health Research Institute /ID# 253461, Sun City, Arizona, United States
- Parkinson's Research Centers of America - Palo Alto /ID# 264703, Palo Alto, California, United States
- Georgetown University Hospital /ID# 259381, Washington D.C., District of Columbia, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465, Boca Raton, Florida, United States
- University of Florida College of Medicine /ID# 259383, Gainesville, Florida, United States
- University of Miami /ID# 259396, Miami, Florida, United States
- N1 Research, LLC /ID# 264221, Orlando, Florida, United States
- University of South Florida- Neuroscience Institute /ID# 253470, Tampa, Florida, United States
- Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977, Chicago, Illinois, United States
- Ochsner Medical Center - Jefferson Highway /ID# 269764, New Orleans, Louisiana, United States
- Boston Medical Center Health System /ID# 269765, Brighton, Massachusetts, United States
- University of Minnesota - Minneapolis /ID# 268121, Minneapolis, Minnesota, United States
- Kansas City VA Medical Center /ID# 253466, Kansas City, Missouri, United States
- Cleveland Clinic Lou Ruvo Cent /ID# 259390, Las Vegas, Nevada, United States
- David L. Kreitzman, MD, PC /ID# 259397, Commack, New York, United States
- Northwell Health /ID# 253469, Lake Success, New York, United States
- Novant Health Neurology and Sleep /ID# 259391, Charlotte, North Carolina, United States
- Atrium Health Wake Forest Baptist Medical Center /ID# 259387, Winston-Salem, North Carolina, United States
- NeuroCare Center /ID# 259392, Canton, Ohio, United States
And 48 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see whether ABBV-951, a continuous subcutaneous levodopa infusion, provides durable real-world control of motor symptoms and reduces off time and fluctuations in people with advanced, levodopa-responsive Parkinson's. ABBV-951 delivers levodopa continuously under the skin via an infusion pump to keep steadier blood levels than intermittent oral doses, which may smooth out on/off swings and could reduce peak-dose dyskinesia; because it is levodopa, it directly replaces or supplements oral levodopa rather than working on a different pathway. The study is looking for adults 18 and older with idiopathic, levodopa-responsive PD who are either starting ABBV-951 per local label or who previously completed specific ABBV-951 extension studies, and participants must meet local label rules, have acceptable cognitive status (MMSE 24+ or 19,23 with a permanent caregiver), with exclusions for label contraindications, significant skin issues, or enrollment in other interventional trials. About 450 people worldwide will be followed in routine clinical practice to collect long-term real-world outcomes.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 68 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 3 months.