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Recruiting NCT07313176

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

— Observational Advanced Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention.
Who it may be relevant to
Registry conditions: Advanced Parkinson Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 5 centers
  • 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

Identifiers

NCT: NCT07313176 · NIS-MA-2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗