進行期パーキンソン病患者におけるレボドパ・エンタカポン・カルビドパ腸用ゲルの長期有効性 (SWITCH-ON)
ルーチンケアで皮下投与フォスレボドパを既往に有するパーキンソン病患者におけるレボドパ・エンタカポン・カルビドパ腸用ゲル（LECIGON®）の長期有効性に関する前向き非介入研究
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).
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
London、イギリス、WC1N3BG
- National Hospital for Neurology and Neurosurgery
-
Newcastle upon Tyne、イギリス、NE46BE
- Newcastle upon Tyne Hospitals NHS Foundation Trust
-
-
-
-
A Coruña
-
A Coruña、A Coruña、スペイン、15006
- Complejo Hospitalario Universitario de A Coruña (CHUAC)
-
-
-
-
-
Stadtroda、ドイツ、07646
- Asklepios Fachklinikum Stadtroda GmbH
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
臨床全般改善印象の変化（CGI-C）により測定された臨床全般改善印象のベースラインからの変化
時間枠：ベースライン、6ヵ月および12ヵ月
|
ベースライン、6ヵ月および12ヵ月
|
|
|
12か月時点における患者の全般的変化印象（PGI-C）により測定された臨床的全体印象改善度のベースラインからの変化
時間枠：ベースライン、6か月後および12か月後
|
ベースライン、6か月後および12か月後
|
|
|
ベースラインからのボディマス指数（BMI）の変化
時間枠：ベースライン、6か月および12か月
|
ベースライン、6か月および12か月
|
|
|
Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
捜査官
- スタディディレクター：Mark Watt、Britannia Pharmacetuicals
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。