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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 24, 2024
Primary Completion Date
May 1, 2029
Completion Date
May 1, 2029
Last Updated
December 24, 2025
450
ESTIMATED participants
Lead Sponsor
AbbVie
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07322887