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

NCT07227896 | Not Yet Recruiting

• 1 other identifier: P25-758
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Foslevodopa/Foscarbidopa

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to approximately 6 months

Secondary Outcomes (11)

• Change From Baseline in Dyskinesia presence as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

  Up to approximately 6 months

• Change From Baseline in Dyskinesia duration (absolute hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

  Up to approximately 6 months

• Change From Baseline in Motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV

  Up to approximately 6 months

• Change From Baseline in Disease-specific Quality of Life (QoL) as measured by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index

  Up to approximately 6 months

• Change From Baseline in Generic Quality of Life (QoL) as measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)

  Up to approximately 6 months

Other Outcomes (9)

• Change From Baseline in morning akinesia (early morning "off") as measured by by dedicated questionnaire.

  Up to approximately 6 months

• Change From Baseline in Activities of daily living/independence as measured by the Schwab-England Activities of Daily Living Scale (SE-ADL)

  Up to approximately 6 months

• Change From Baseline in Self-efficacy as measured by the Self-efficacy for Managing Chronic Disease Scale (SEMCD)

  Up to approximately 6 months

Study Arms (1)

Foslevodopa/Foscarbidopa

Participants will receive Foslevodopa/Foscarbidopa as prescribed by their physician according to local label.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with earlier within advanced Parkinson disease receiving Foslevodopa/Foscarbidopa treatment in accordance with the local label requirements in the participating country.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Boston Medical Center Health System

Boston, Massachusetts, 02118, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Lars Bergmann

CONTACT

+49(0)170 4538568; lars.bergmann@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 13, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)