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

Britannia Pharmaceuticals

Status: Enrolling

Conditions: Advanced Parkinson Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT07313176

NIS-MA-2025-01

Details and patient eligibility

About

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).

Enrollment: 215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

215 participants in 1 patient group

Participants Receiving LECIGON® Treatment

Description:

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.

Treatment:

Other: No Intervention