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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Time since motor fluctuations ≤3 years
* H\&Y Stage \<3 in best "on"
* "off" time of 2.5-6 hours per day
* Naïve to LDp/CDp
* Treatment has been optimized with oral/transdermal PD medication in the opinion of the Investigator
* Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in the study
* Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet).
* Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use/Disclosure of Data (AUDD)/Informed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered
Exclusion Criteria:
* 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
* Lack of motivation/insufficient language skills to complete the study questionnaires
* History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the participant should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.
Primary outcome measure(s)
Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV — Up to approximately 6 months 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)
Trial sites (10)
Facility
City
Region
Status
Texas Movement Disorder Specialists /ID# 278565
Georgetown
Texas
Recruiting
Shaare Zedek Medical Center /ID# 276209
Jerusalem
Jerusalem
Recruiting
The Chaim Sheba Medical Center /ID# 276210
Ramat Gan
Tel Aviv
Recruiting
Tel Aviv Sourasky Medical Center /ID# 276212
Tel Aviv
Tel Aviv
Recruiting
Hadassah Medical Center-Hebrew University /ID# 276211
Jerusalem
Israel
Recruiting
Fundeni Clinical Institute /ID# 277490
Bucharest
Bucharest
Recruiting
Arcadia Spitale Si Centre Medicale /Id# 277525
Iași
Iaşi
Recruiting
Neurotim Med /ID# 277500
Timișoara
Timiș County
Recruiting
Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499
Brasov
Romania
Not Yet Recruiting
University Hospitals Plymouth NHS Trust /ID# 284977
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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