진행성 파킨슨병 환자를 대상으로 한 레보도파-엔타카폰-카르비도파 장용겔의 장기적 효과 (SWITCH-ON)
루틴 치료에서 피하 포스레보도파를 이전에 투여받은 파킨슨병 환자에서 레보도파-엔타카폰-카르비도파 장용형 젤(LECIGON®)의 장기적 유효성에 관한 전향적 비개입 연구
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).
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Stadtroda, 독일, 07646
- Asklepios Fachklinikum Stadtroda GmbH
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A Coruña
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A Coruña, A Coruña, 스페인, 15006
- Complejo Hospitalario Universitario de A Coruña (CHUAC)
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London, 영국, WC1N3BG
- National Hospital for Neurology and Neurosurgery
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Newcastle upon Tyne, 영국, NE46BE
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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
기간: Baseline, Month 12
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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임상 전반적 변화(CGI-C)로 측정한 임상 전반적 호전도 기준점 대비 변화
기간: 기준선, 6개월 및 12개월
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기준선, 6개월 및 12개월
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12개월 시점의 환자 전반적 변화 인상척도(PGI-C)로 측정한 임상 전반적 호전 인상 척도의 기저선 대비 변화
기간: 기준선, 6개월 및 12개월
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기준선, 6개월 및 12개월
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기준선 대비 체질량 지수(BMI) 변화
기간: 기준선, 6개월 및 12개월
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기준선, 6개월 및 12개월
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Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
기간: Baseline, Month 6
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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
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Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries
기간: Baseline, Months 6 and 12
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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
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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
기간: Baseline, Months 6 and 12
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Total daily levodopa dose will be measured using the multi-rate programming of pump. |
Baseline, Months 6 and 12
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Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
기간: Baseline, Months 6 and 12
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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
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Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV
기간: Baseline, Months 6 and 12
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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
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Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8)
기간: Baseline, Months 6 and 12
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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
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Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)
기간: Baseline, Months 6 and 12
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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
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Treatment Satisfaction Questionnaire at Months 6 and 12
기간: At Months 6 and 12
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Participants will be asked questions to assess their satisfaction with LECIGON® treatment. |
At Months 6 and 12
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Number of Participants With Adverse Drug Reactions (ADRs), Serious ADRs, Reportable Events (REs), Serious REs and REs of Special Interest (RESIs)
기간: 12 months
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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
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공동 작업자 및 조사자
수사관
- 연구 책임자: Mark Watt, Britannia Pharmacetuicals
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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