A Study to Assess Change in Disease Symptoms in Adult Participants With Advanced Parkinson Disease Using Subcutaneous Foslevodopa/Foscarbidopa in Belgium (ProParkB)

April 6, 2026 updated by: AbbVie

Observational Prospective Study to Evaluate Effectiveness of Subcutaneous Treatment With Foslevodopa/Foscarbidopa in Real Life Setting for Advanced Parkinson's Disease Patients in Belgium.

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 with advanced Parkinson Disease under routine clinical practice in Belgium.

Foslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 120 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled at 15 sites across Belgium.

Participants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 18 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen /ID# 279434
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
        • Recruiting
        • Chu Tivoli /ID# 279455
      • Tournai, Hainaut, Belgium, 7500
        • Recruiting
        • Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 279452
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis - Campus Virga Jesse /ID# 279454
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent /ID# 279433
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven /ID# 279439
    • West-Vlaanderen
      • Bruges, West-Vlaanderen, Belgium, 8000
        • Recruiting
        • AZ Sint-Jan Brugge /ID# 279422
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • Recruiting
        • Az Groeninge Campus Kennedylaan /ID# 279423
      • Ostend, West-Vlaanderen, Belgium, 8400
        • Recruiting
        • AZ Oostende /ID# 279461
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ-Delta. /ID# 279437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with advanced Parkinson's Disease receiving Foslevodopa/Foscarbidopa treatment in accordance with the local label requirements in Belgium.

Description

Inclusion Criteria:

  • Participant diagnosed with Advanced Parkinson's Disease (PD), aged 18 years or older able to provide voluntary informed consent.
  • Participant evaluated for commercially available continuous subcutaneous Foslevodopa/Foscarbidopa (LDp/CDp) in the hospital at the clinician's discretion as part of his/her routine clinical care and the intention to administer subcutaneous LDp/CDp made prior to and independent of recruitment into the study.

Exclusion Criteria:

  • Participant participating in an interventional research study (not including noninterventional studies) during the administration of LDp/CDp.
  • Participant evaluated for commercially available continuous subcutaneous LD/CDp outside of the hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in OFF Time (hours) as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) IV
Time Frame: 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)
Up to approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P26-053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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