- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07313176
Efectividad a Largo Plazo del Gel Intestinal de Levodopa-Entacapona-Carbidopa en Participantes con Enfermedad de Parkinson Avanzada (SWITCH-ON)
Un estudio prospectivo, no intervencionista sobre la eficacia a largo plazo del gel intestinal de levodopa-entacapona-carbidopa (LECIGON®) en pacientes con enfermedad de Parkinson tratados previamente con foslevodopa subcutánea en la atención de rutina
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Stadtroda, Alemania, 07646
- Asklepios Fachklinikum Stadtroda GmbH
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A Coruña
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A Coruña, A Coruña, España, 15006
- Complejo Hospitalario Universitario de A Coruña (CHUAC)
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London, Reino Unido, WC1N3BG
- National Hospital for Neurology and Neurosurgery
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Newcastle upon Tyne, Reino Unido, NE46BE
- Newcastle upon Tyne Hospitals NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambio desde la línea de base en la Impresión Clínica Global de Mejora medido mediante la Impresión Clínica Global de Cambio (CGI-C)
Periodo de tiempo: Baseline, Meses 6 y 12
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Baseline, Meses 6 y 12
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Cambio desde la línea de base en la Impresión Clínica Global de Mejoría según lo medido por la Impresión Global del Paciente de Cambio (PGI-C) a los 12 meses
Periodo de tiempo: Línea de base, Meses 6 y 12
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Línea de base, Meses 6 y 12
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Cambio desde la línea de base en el índice de masa corporal (IMC)
Periodo de tiempo: Baseline, Meses 6 y 12
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Baseline, Meses 6 y 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mark Watt, Britannia Pharmacetuicals
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NIS-MA-2025-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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