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.
Study Type
OBSERVATIONAL
Enrollment
450
University of Alabama at Birmingham - Main /ID# 253477
Birmingham, Alabama, United States
RECRUITINGBanner Sun Health Research Institute /ID# 253461
Sun City, Arizona, United States
RECRUITINGParkinson's Research Centers of America - Palo Alto /ID# 264703
Palo Alto, California, United States
RECRUITINGGeorgetown University Hospital /ID# 259381
Washington D.C., District of Columbia, United States
Change From Baseline in OFF Time (hours)
The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465
Boca Raton, Florida, United States
RECRUITINGUniversity of Florida College of Medicine /ID# 259383
Gainesville, Florida, United States
RECRUITINGUniversity of Miami /ID# 259396
Miami, Florida, United States
RECRUITINGN1 Research, LLC /ID# 264221
Orlando, Florida, United States
RECRUITINGUniversity of South Florida- Neuroscience Institute /ID# 253470
Tampa, Florida, United States
RECRUITINGNorthwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977
Chicago, Illinois, United States
RECRUITING...and 58 more locations