Actively Recruiting
Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease
Led by Britannia Pharmaceuticals Ltd. · Updated on 2026-01-21
215
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old and over with advanced Parkinson's disease with severe motor fluctuations and dyskinesia
- Decision by treating physician to start LECIGON4 treatment according to product guidelines
- Previous treatment with subcutaneous foslevodopa for at least 1 month
- Signed informed consent by participant or legal representative
You will not qualify if you...
- Contraindications to LECIGON4 as defined by current product guidelines
- Patients not expected to return for follow-up care at the study site after starting LECIGON4
- Anticipated problems with pump placement or use, including acute severe illness, inability to perform pump therapy, severe dementia, agitation, or alcohol abuse
- Participation in another interventional clinical trial at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Virgen del Rocío University Hospital
Seville, Av. Manuel Siurot, S/n, Spain, 41013
Actively Recruiting
2
Complejo Hospitalario Universitario de A Coruña (CHUAC)
A Coruña, Spain, 15006
Actively Recruiting
Research Team
S
Sukhdeep Singh, MSci
CONTACT
N
Niall Smith, MBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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