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.
• Eligibility for ABBV-951 therapy in accordance with the approved local label in the participating country and local reimbursement regulations, if applicable.
• Diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD).
• Participant must be either:
‣ Cohort A: Naïve to ABBV-951
⁃ Cohort B: Pre-treated with ABBV-951, specifically, participants of Open-Label Extension Studies M15-737 and M20-098 who completed these studies without significant protocol deviations and who did not experience an adverse event (AE) that in the investigator's opinion may indicate an unacceptable safety risk.
• Decision to treat with ABBV-951 (or continue the treatment in Cohort B) made by the clinician prior to any decision to approach the participant to participate in this study.
• Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the participant has had the opportunity to have questions answered.