RecruitingNCT07313176

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

Sponsor

Britannia Pharmaceuticals Ltd.

Enrollment

215 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Advanced Parkinson Disease

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study tracks how well a gel called LECIGON® (levodopa-entacapone-carbidopa intestinal gel) works over the long term in people with advanced Parkinson's disease who have severe motor fluctuations. It is for patients who previously used a different gel treatment (foslevodopa) and are now switching. **You may be eligible if...** - You are an adult (18+) with advanced Parkinson's disease - You have severe motor fluctuations and dyskinesia (uncontrolled movements) - Your doctor has decided to start you on LECIGON® based on your clinical need - You have previously received foslevodopa treatment for at least 1 month **You may NOT be eligible if...** - You have contraindications to LECIGON® as listed in its official prescribing information - You have not had prior foslevodopa treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Intervention

This is a non-interventional study.

Locations(2)

Virgen del Rocío University Hospital

Seville, Av. Manuel Siurot, S/n, Spain

Complejo Hospitalario Universitario de A Coruña (CHUAC)

A Coruña, Spain

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NCT07313176