Long Term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel in Participants With Advanced Parkinson's Disease
Recruiting · NCT07313176 · Observational (researchers observe without assigning treatment) · Lead sponsor: Britannia Pharmaceuticals Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
No Intervention
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
5 locations listed.
- Complejo Hospitalario Universitario de A Coruña (CHUAC) - A Coruña, A Coruña, Spain
- Virgen del Rocío University Hospital - Seville, Av. Manuel Siurot, S/n, Spain
- Hospital Universitario de Toledo - Toledo, Castille-La Mancha, Spain
- Hospital de Cruces - Barakaldo, Vizcaya, Spain
- Hospital de Basurto - Bilbao, Vizcaya, Spain