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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 427
- 试验地点
- 135
- 主要终点
- Change From Baseline in OFF Time (hours)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Any condition included in the contraindications section of the approved local ABBV-951 label in the participating country.
- •Mini-Mental State Examination (MMSE) score <
- •If the participant has a score of 19-23, he/she can be included if based on the investigator´s judgment the participant is able to handle the therapy and follow the study procedures with the help of a permanent caregiver.
- •Participation in a concurrent interventional clinical trial from enrollment and throughout the study.
- •History of significant skin conditions or disorders per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the participant should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments.
研究组 & 干预措施
Cohort A: ABBV-951
Participants naïve to ABBV-951 will receive ABBV-951 as prescribed by their physician according to the local label.
Cohort B: ABBV-951
Participants transitioning from the Open-Label Extension studies M15-737 and M20-098 will continue to receive ABBV-951.
Country Specific Sub-Study
Participants located in the United States, Germany and Spain, that participated in Cohort A, will participate in a single initial interview and those who continue on the treatment after 6 months will participate in a follow-up interview to explore the longitudinal impact of the treatment. Those participants who discontinue prior to the 6 months time point will engage in a discontinuation interview to understand reasons for their discontinuation of treatment.
结局指标
主要结局
Change From Baseline in OFF Time (hours)
时间窗: Up to approximately 3 years
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).
次要结局
未报告次要终点