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

NCT07382440 | Not Yet Recruiting

• 1 other identifier: P26-053
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease: Advanced 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

Study Arms (1)

Foslevodopa/Foscarbidopa

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• AbbVie: lead

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

Clementine Semanaz

CONTACT

32 496505384; clementine.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: January 28, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01