NCT07382440

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

January 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

January 27, 2026

Last Update Submit

July 8, 2026

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease: Advanced Parkinson's DiseaseFoslevodopa/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

Study Arms (1)

Foslevodopa/Foscarbidopa

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Imelda Ziekenhuis /ID# 279436

Bonheiden, Antwerpen, 2820, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen /ID# 279434

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Chu Tivoli /ID# 279455

La Louvière, Hainaut, 7100, Belgium

RECRUITING

Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 279452

Tournai, Hainaut, 7500, Belgium

RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse /ID# 279454

Hasselt, Limburg, 3500, Belgium

RECRUITING

AZ Sint-Lucas /ID# 279453

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Gent /ID# 279433

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven /ID# 279439

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Algemeen Ziekenhuis Sint-Jan Brugge /ID# 279422

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

Az Groeninge Campus Kennedylaan /ID# 279423

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

AZ Oostende /ID# 279461

Ostend, West-Vlaanderen, 8400, Belgium

RECRUITING

AZ-Delta. /ID# 279437

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

Clementine Semanaz

CONTACT

844-663-3742clementine.semanaz@abbvie.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 2, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations

BE(12)