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Clinical Trials in the USA / NCT07227896
Recruiting Observational

Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease

NCT07227896 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Observational
Started
2026-08-03
Last updated
2026-09-01

Condition(s) studied

Parkinson's Disease

Study summary

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)

Trial sites (10)

FacilityCityRegionStatus
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 Plymouth Devon Recruiting

More AbbVie trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT07227896 on ClinicalTrials.gov ↗ ← All trials in the USA