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NCT07313176Terminated

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

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

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Terminated
Study type
Observational
Enrollment
1 (actual)
First submitted
17 Dec 2025
Start date
8 May 2026
Primary completion date
31 Aug 2026
Lead sponsor
Britannia Pharmaceuticals Ltd.
NCT number
NCT07313176

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who will not be seen again for their follow up care at the investigator's site after commencement of LECIGON® therapy

Other illness

  • 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

Other

  • Participants with contraindications as defined in the current version of the SmPC for LECIGON®
  • Participants taking part in a clinical (interventional) trial at the same time

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Asklepios Fachklinikum Stadtroda GmbH
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StadtrodaGermanyUnknown status
Complejo Hospitalario Universitario de A Coruña (CHUAC)
Coordinator of this site? Confirm its status
A CoruñaSpainUnknown status
National Hospital For Neurology and Neurosurgery
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.