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Идёт набор NCT07313176

Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease

— Наблюдательное Advanced Parkinson Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Intervention.
Кому может быть актуально
Состояния в реестре: Advanced Parkinson Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

A Prospective, Non-Interventional Study on the Long-term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel (LECIGON®) in Patients With Parkinson's Disease Previously Treated With Subcutaneous Foslevodopa in Routine Care

Обзор

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).

Вмешательства

  • Другое No Intervention
    This is a non-interventional study.

Первичные конечные точки

  • 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 [Срок оценки: Baseline, Month 12]
Вторичные конечные точки (12)
  • Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months [Срок оценки: Baseline, Month 6]
  • Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries [Срок оценки: 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 [Срок оценки: Baseline, Months 6 and 12]
  • Change from Baseline in Clinical Global Impression of Improvement as Measured by Clinical Global Impression of Change (CGI-C) [Срок оценки: Baseline, Months 6 and 12]
  • Change from Baseline in Clinical Global Impression of Improvement as Measured by Patient Global Impression of Change (PGI-C) at 12 months [Срок оценки: Baseline, Months 6 and 12]
  • Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I [Срок оценки: Baseline, Months 6 and 12]
  • Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV [Срок оценки: Baseline, Months 6 and 12]
  • Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8) [Срок оценки: Baseline, Months 6 and 12]
  • Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2) [Срок оценки: Baseline, Months 6 and 12]
  • Treatment Satisfaction Questionnaire at Months 6 and 12 [Срок оценки: At Months 6 and 12]
  • Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, 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) [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 5 центров
  • Complejo Hospitalario Universitario de A Coruña (CHUAC) — A Coruña
  • Virgen del Rocío University Hospital — Seville
  • Hospital Universitario de Toledo — Toledo
  • Hospital de Cruces — Barakaldo
  • Hospital de Basurto — Bilbao

Идентификаторы

NCT: NCT07313176 · NIS-MA-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗