Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective Foslevodopa/Foscarbidopa is in treating adult participants earlier within advanced Parkinson disease under routine clinical practice.
Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 100 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 40 sites across the world.
Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 6 months.
There are no additional examinations due to the study but the participants and caregivers will need to fill several questionnaires to generate data on their motor function and well-being
Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable
A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)
Adult male or female between 18 and 80 years of age
Disease duration (time since diagnosis) <10 years
History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country
History of treatment with any Device-Aided Therapy (DAT), such as Deep Brain Stimulation (DBS), Continuous Subcutaneous Apomorphine Infusion (CSAI), Levodopa/Carbidopa Intestinal Gel (LCIG)/ Carbidopa/Levodopa Enteral Suspension (CLES), Levodopa/Entacapone/Carbidopa Intestinal Gel (LECIG)
Mini-Mental State Examination (MMSE) score <24
Participation in a concurrent investigational or observational clinical trial
Participants with earlier within advanced Parkinson disease receiving Foslevodopa/Foscarbidopa treatment in accordance with the local label requirements in the participating country.
Cohort
Prospective
Not listed
Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD)
Change From Baseline in Dyskinesia presence as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)
Change From Baseline in Dyskinesia duration (absolute hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD).
Change From Baseline in Motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). (The numeric score for each question is between 0-4; 0=Normal, 4=Severe)
Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index
The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable).
Change From Baseline in morning akinesia (early morning "off") as measured by by dedicated questionnaire.
Measured by dedicated questionnaire.
Change From Baseline in Activities of daily living/independence as measured by the Schwab-England Activities of Daily Living Scale (SE-ADL)
Schwab-England Activities of Daily Living Scale (SE-ADL) onsists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.
Change From Baseline in Self-efficacy as measured by the Self-efficacy for Managing Chronic Disease Scale (SEMCD)
Self-efficacy for Managing Chronic Disease Scale (SEMCD) Self-efficacy for chronic disease will be measured.
Change From Baseline in Ability to reintegrate into normal social activity after illness as measured by the Reintegration to Normal Living Scale (RNLI) Scale
Reintegration to Normal Living Scale (RNLI) Scale the reintegrate into normal social activity after illness will be measured
