NCT07313176招募中不适用
A Prospective, Non-Interventional Study on the Long-term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel (LECIGON®) in Patients With Parkinson's Disease Previously Treated With Subcutaneous Foslevodopa in Routine Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 5
- 主要终点
- Change from Baseline in the Reduction in OFF time (h/day) as Measured by Movement Disorder Society-unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV) at 12 months
研究概览
简要总结
The primary objective of the study is to assess the effectiveness of LECIGON® treatment on the reduction in OFF time (h/day) from baseline at 12 months as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV).
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
- •Adult participants (18 years old and over) with advanced Parkinson's disease with severe motor fluctuations and dyskinesia
- •Participants for whom the treating physician has made the decision to initiate treatment with LECIGON® in accordance with the Summary of Product Characteristics (SmPC)
- •Participants must have had previous treatment with subcutaneous foslevodopa (foslevodopa-foscarbidopa) for a minimum of 1 month
- •Participants or legal representative must have signed informed consent to participate in the study
排除标准
- •Participants with contraindications as defined in the current version of the SmPC for LECIGON®
- •Participants who will not be seen again for their follow up care at the investigator's site after commencement of LECIGON® therapy
- •Participants with anticipated pump placement or pump use issues, e.g. participants with acute severe illness, participants unable to perform pump therapy, and in case of lacking compliance due to severe dementia, agitation or alcohol abuse
- •Participants taking part in a clinical (interventional) trial at the same time
结局指标
主要结局
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Movement Disorder Society-unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV) at 12 months
时间窗: Baseline, Month 12
The MDS-UPDRS is a revision of the Unified Parkinson's disease rating scale (UPDRS) developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part IV concerns motor complication and all questions in Part IV that deal with motor fluctuations and dyskinesias, the investigator is required to conduct the interview of participants.
次要结局
- Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months(Baseline, Month 6)
- Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries(Baseline, Months 6 and 12)
- Change from Baseline in LECIGON® Treatment Patterns due to Change in Daily Levodopa Dose (mg/day) as Measured by Total Daily Dose Using Multi-rate Programming of Pump(Baseline, Months 6 and 12)
- Change from Baseline in Clinical Global Impression of Improvement as Measured by Clinical Global Impression of Change (CGI-C)(Baseline, Months 6 and 12)
- Change from Baseline in Clinical Global Impression of Improvement as Measured by Patient Global Impression of Change (PGI-C) at 12 months(Baseline, Months 6 and 12)
- Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I(Baseline, Months 6 and 12)
- Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV(Baseline, Months 6 and 12)
- Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8)(Baseline, Months 6 and 12)
- Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)(Baseline, Months 6 and 12)
- Treatment Satisfaction Questionnaire at Months 6 and 12(At Months 6 and 12)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Months 6 and 12)
- Number of Participants With Adverse Drug Reactions (ADRs), Serious ADRs, Reportable Events (REs), Serious REs and REs of Special Interest (RESIs)(12 months)
研究者
研究点 (5)
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