Dlouhodobá účinnost střevního gelu s levodopou, entakaponem a karbidopou u účastníků s pokročilou Parkinsonovou chorobou (SWITCH-ON)
Prospektivní, neintervenční studie o dlouhodobé účinnosti střevního gelu levodopa-entakapon-karbidopa (LECIGON®) u pacientů s Parkinsonovou chorobou dříve léčených subkutánním foslevodopou v běžné péči
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).
Přehled studie
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Stadtroda, Německo, 07646
- Asklepios Fachklinikum Stadtroda GmbH
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London, Spojené království, WC1N3BG
- National Hospital for Neurology and Neurosurgery
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Newcastle upon Tyne, Spojené království, NE46BE
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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A Coruña
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A Coruña, A Coruña, Španělsko, 15006
- Complejo Hospitalario Universitario de A Coruña (CHUAC)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Změna od výchozího stavu v klinickém celkovém dojmu zlepšení měřeném pomocí klinického celkového dojmu ze změny (CGI-C)
Časové okno: Výchozí hodnota, 6. a 12. měsíc
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Výchozí hodnota, 6. a 12. měsíc
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Změna oproti výchozí hodnotě v klinickém celkovém dojmu zlepšení podle pacientova celkového dojmu ze změny (PGI-C) po 12 měsících
Časové okno: Výchozí hodnota, 6. a 12. měsíc
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Výchozí hodnota, 6. a 12. měsíc
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Změna oproti výchozí hodnotě indexu tělesné hmotnosti (BMI)
Časové okno: Výchozí hodnoty, měsíc 6 a 12
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Výchozí hodnoty, měsíc 6 a 12
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Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Mark Watt, Britannia Pharmacetuicals
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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