No Intervention: This is a non-interventional study.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Movement Disorder Society-unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV) at 12 months — Baseline, Month 12 The MDS-UPDRS is a revision of the Unified Parkinson's disease rating scale (UPDRS) developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part IV concerns motor complication and all questions in Part IV that deal with motor fluctuations and dyskinesias, the investigator is required to conduct the interview of participants.
Trial sites (5)
Facility
City
Region
Status
Complejo Hospitalario Universitario de A Coruña (CHUAC)
A Coruña
A Coruña
Recruiting
Virgen del Rocío University Hospital
Seville
Av. Manuel Siurot, S/n
Recruiting
Hospital Universitario de Toledo
Toledo
Castille-La Mancha
Recruiting
Hospital de Cruces
Barakaldo
Vizcaya
Recruiting
Hospital de Basurto
Bilbao
Vizcaya
Recruiting
More Britannia Pharmaceuticals Ltd. trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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