- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07313176
Långtidseffektiviteten av Levodopa-Entacapone-Carbidopa-tarmgel för deltagare med avancerad Parkinsons sjukdom (SWITCH-ON)
En prospektiv, icke-interventionell studie om den långsiktiga effektiviteten av Levodopa-Entacapon-Carbidopa-tarmgel (LECIGON®) hos patienter med Parkinsons sjukdom som tidigare behandlats med subkutan Foslevodopa i rutinmässig vård
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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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A Coruña
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A Coruña, A Coruña, Spanien, 15006
- Complejo Hospitalario Universitario de A Coruña (CHUAC)
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London, Storbritannien, WC1N3BG
- National Hospital for Neurology and Neurosurgery
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Newcastle upon Tyne, Storbritannien, NE46BE
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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Stadtroda, Tyskland, 07646
- Asklepios Fachklinikum Stadtroda GmbH
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Förändring från baslinjen i klinisk global bild av förbättring enligt Clinical Global Impression of Change (CGI-C)
Tidsram: Baslinje, månad 6 och 12
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Baslinje, månad 6 och 12
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Förändring från baslinjen i klinisk global bedömning av förbättring mätt med Patient Global Impression of Change (PGI-C) vid 12 månader
Tidsram: Baslinje, månad 6 och 12
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Baslinje, månad 6 och 12
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Förändring från baslinjen i kroppsmassaindex (BMI)
Tidsram: Baseline, månad 6 och 12
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Baseline, månad 6 och 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Mark Watt, Britannia Pharmacetuicals
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-MA-2025-01
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