Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease
Recruiting now
Conditions studied: Advanced Parkinson Disease
In brief
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).
Key facts
- Study ID
- NCT07313176
- Run by
- Britannia Pharmaceuticals Ltd.
- People needed
- 215
- Starts
- 2026-05-08
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Complejo Hospitalario Universitario de A Coruña (CHUAC) — A Coruña, A Coruña, Spain (enrolling)
- Virgen del Rocío University Hospital — Seville, Av. Manuel Siurot, S/n, Spain (enrolling)
- Hospital Universitario de Toledo — Toledo, Castille-La Mancha, Spain (enrolling)
- Hospital de Cruces — Barakaldo, Vizcaya, Spain (enrolling)
- Hospital de Basurto — Bilbao, Vizcaya, Spain (enrolling)
Full record on ClinicalTrials.gov
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