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左旋多巴-恩他卡朋-卡比多巴肠道凝胶在晚期帕金森病患者中的长期有效性 (SWITCH-ON)

2026年9月29日 更新者:Britannia Pharmaceuticals Ltd.

一项关于左旋多巴-恩他卡朋-卡比多巴肠凝胶(LECIGON®)在既往接受皮下左旋多巴治疗的帕金森病患者常规护理中长期有效性的前瞻性、非干预性研究

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).

研究概览

地位

终止

研究类型

观察性的

注册 (实际的)

1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Stadtroda、德国、07646
        • Asklepios Fachklinikum Stadtroda GmbH
      • London、英国、WC1N3BG
        • National Hospital for Neurology and Neurosurgery
      • Newcastle upon Tyne、英国、NE46BE
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
    • A Coruña
      • A Coruña、A Coruña、西班牙、15006
        • Complejo Hospitalario Universitario de A Coruña (CHUAC)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult participants with advanced Parkinson's disease have discontinued treatment with foslevodopa-foscarbidopa and are receiving LECIGON® as part of their routine care will be included in this observational study.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Participants Receiving LECIGON® Treatment

All participants with advanced Parkinson's disease who switched from subcutaneous foslevodopa (foslevodopa-foscarbidopa) to LECIGON®, will be observed in the study. Participants real-world data on the long-term effectiveness of LECIGON® in routine clinical practice will be observed.

This is a non-interventional study.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
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
大体时间: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.

Baseline, Month 12

次要结果测量

结果测量
措施说明
大体时间
通过临床总体印象变化量表(CGI-C)测量的临床总体印象改善相对于基线的变化
大体时间:基线、第6个月和第12个月
基线、第6个月和第12个月
12个月时通过患者整体印象变化量表(PGI-C)测量的临床整体印象改善相对于基线的变化
大体时间:基线、第6个月和第12个月
基线、第6个月和第12个月
基线与体质量指数(BMI)的变化
大体时间:基线、第6个月和第12个月
基线、第6个月和第12个月
Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
大体时间:Baseline, Month 6

The MDS-UPDRS is a revision of the 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.

Baseline, Month 6
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries
大体时间:Baseline, Months 6 and 12

The Hauser Diary is a home diary, completed by the participant, that assesses functional status in participants with Parkinson's disease with motor fluctuations and dyskinesia. Participants will complete the Hauser Diary for a 72-hour period occurring after informed consent has been obtained and prior to LECIGON® treatment start and for 48 hours prior to each of the two follow-up visits.

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
大体时间:Baseline, Months 6 and 12

Total daily levodopa dose will be measured using the multi-rate programming of pump.

Baseline, Months 6 and 12
Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
大体时间:Baseline, Months 6 and 12

The MDS-UPDRS is a revision of the UPDRS developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I concerns non-motor experiences of daily living. Several questions from Part I are designed to be amenable to a patient/caregiver questionnaire format and therefore can be completed without the investigator's input. For the remaining Part I questions that deal with complex behaviors, the investigator is required to conduct the interview of participants.

Baseline, Months 6 and 12
Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV
大体时间:Baseline, Months 6 and 12

The MDS-UPDRS is a revision of the 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.

Baseline, Months 6 and 12
Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8)
大体时间:Baseline, Months 6 and 12

The PDQ-8 is an eight-question instrument, completed by the participants, that measures the quality of life among Parkinson's disease participants. It is a shortened version of the 39-item Parkinson's disease questionnaire to reduce participant burden and increase convenience for use among Parkinson's disease participants. It includes one question from each of the dimensions including include mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.

Baseline, Months 6 and 12
Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)
大体时间:Baseline, Months 6 and 12

The PDSS is a visual analogue scale, completed by the Parkinson's disease participant, addressing 15 commonly reported symptoms associated with sleep disturbances, including overall quality of night's sleep, sleep onset and maintenance insomnia, nocturnal restlessness, nocturnal psychosis, nocturia, nocturnal motor symptoms, sleep refreshment, and daytime dozing. The PDSS-2 uses a 5-point frequency scale (0-4) for each item, with a total score ranging from 0 to 60. Higher scores indicate more severe sleep problems.

Baseline, Months 6 and 12
Treatment Satisfaction Questionnaire at Months 6 and 12
大体时间:At Months 6 and 12

Participants will be asked questions to assess their satisfaction with LECIGON® treatment.

At 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)
大体时间:12 months

An ADR is any untoward and unintended response to a medicinal product, related to any dose administered and which implies a RE with at least a reasonable possibility of a causal relationship with the use of the product. A RE is any unfavorable or unintended sign, symptom or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. RESIs include drug interaction, drug exposure during pregnancy, drug exposure during breastfeeding, lack of drug efficacy, overdose, misuse/abuse, medication errors (incl. prescription and application errors), off-label use, adverse reaction which occurred during occupational exposure, falsified medicinal product, suspected transmission of infectious agents via a medicinal product.

12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Mark Watt、Britannia Pharmacetuicals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月8日

初级完成 (实际的)

2026年8月31日

研究完成 (实际的)

2026年8月31日

研究注册日期

首次提交

2025年12月17日

首先提交符合 QC 标准的

2025年12月17日

首次发布 (实际的)

2025年12月31日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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