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NCT Number: NCT07382440

A Study to Assess Change in Disease Symptoms in Adult Participants With Advanced Parkinson Disease Using Subcutaneous Foslevodopa/Foscarbidopa 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imelda Ziekenhuis /ID# 279436, Bonheiden, Antwerpen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Clementine Semanaz

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: ProParkB

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 2, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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